Quality Engineering Manager Resume Samples
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Quality Engineering Manager Resume Samples
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WW
W Witting
Woodrow
Witting
6745 Bergstrom Parkway
New York
NY
+1 (555) 809 7070
6745 Bergstrom Parkway
New York
NY
Phone
p
+1 (555) 809 7070
Experience
Experience
Dallas, TX
Quality Engineering Manager
Dallas, TX
Lockman-Ryan
Dallas, TX
Quality Engineering Manager
- Supplier Quality Management: Support to establish and monitor quality standards for all products and services related to mobile devices. Proactively resolve and prevent product quality issues. Support to implement strong quality management and FMEA processes with each OEM to minimize the impact on customers and operations. Provide feedback to Terminal Management to affect purchasing decisions and Product Development to affect terminal acceptance decisions. Work closely with Product Development and Customer Care regarding customer impact due to quality issues and work with suppliers to resolve in a timely manner
- Coordinates and executes Quality Engineering and Quality Control activities to maintain and improve product quality by executing inspection, measurement and test activities, partnering with Operations regarding production and process controls, leading process risk management activities, supporting product investigations, partnering with Product Development and Operations on design transfer of NPI projects and process validations and partnering with Quality Assurance regarding supplier performance and part qualifications
- Project level test strategy / plan artifacts that support the implementation of shift-left testing and white box/gray box testing objectives such as: component / service level testing, service virtualization, data conversion / system integration testing, continuous build release testing and version control, pairwise / orthogonal array and control flow testing
- Provides clear assignments, helps employees connect their efforts to the bigger picture, creates an inclusive work environment characterized by mutual respect and the valuing of differences, and builds a culture that motivates employees to their highest levels of performance. Influences Leadership development with the focus on strong succession planning and strategic leadership movement and partners with Business leaders to build the leadership depth that supports our Quality Succession Planning process
- Lead the end to end ownership of a Quality Engineering (QE/QA) team, including setting the technical vision for developing test frameworks and automation for our systems
- Work with Application Development to increase unit test coverage and overall code quality
- Be a champion of quality and operational excellence: establish team metrics for measurement of quality and operational excellence and a consistent, regular process for assessment and improvement
San Francisco, CA
Advanced Quality Engineering Manager
San Francisco, CA
Murphy-Gusikowski
San Francisco, CA
Advanced Quality Engineering Manager
- Maintains working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner
- Drive continuous improvement initiatives from a process and systemic perspective to improve Cost of Poor Quality and response time to customers
- Challenge status-quo and develop teams to own and drive continuous improvement mentality
- Plan, develop and improve quality infrastructure (people, process and systems)
- Supports and adheres to policies, procedures, and operational guidelines related to established quality management system (TS 16949)
- Good working knowledge of automated manufacturing processes and End-of-line testers
- Proficiency in working with Microsoft Office tools and other software products
present
Boston, MA
Healthcare Regional Quality & Engineering Manager
Boston, MA
Lemke-Howell
present
Boston, MA
Healthcare Regional Quality & Engineering Manager
present
- Developing and instituting consistent maintenance management practices across the facility portfolio
- Overseeing use of consistent maintenance management key performance indicator reporting
- Implementation and management of the computerized maintenance management systems (Corrigo, TMS, 360)in accordance with JLL and client expectations
- Develops and implements standardized processes for conducting compliance audits at each Hospital to determine Operational Readiness/Preparedness
- Administer/manage the JLL Engineering Services Compliance Program
- Ensure that communication with the engineering and facilities management staff is effective and thorough
- Utilizes field audit data/information to prepare specific action/improvement plans for each Hospital/Site
Education
Education
Bachelor’s Degree in Computer Science
Bachelor’s Degree in Computer Science
Loyola University Chicago
Bachelor’s Degree in Computer Science
Skills
Skills
- 7- 10 years of hands on Quality Engineering or Software Development experience
- Promotes the professional development of the Mission Assurance workforce and fosters a collaborative culture that sustains the momentum around employee engagement and inclusion, affordability, innovation, value growth and
- Able to multitask efficiently and effectively
- Highly organized
- Strong attention to detail
- Excellent communication skills (written and verbal)
- Great interpersonal skills
- Customer-/Quality-focused
- Solid problem solving and time management skills
- Microsoft Office/Suite proficient
15 Quality Engineering Manager resume templates
Read our complete resume writing guides
1
Quality Engineering Manager Resume Examples & Samples
- Responsible for the quality of a number of Products for our Cloud Infrastructure product line
- Accountable for overall design and implementation of testing strategies
- Manage a team of technical Quality Engineers
- Review testing infrastructure and data to ensure proper validation of code
- Follow Agile development methodologies such as Scrum or Kanban
- Organize projects through use of quality engineering resource management and development of test strategies that include security, integration, performance and positive and negative functional test coverage
- Assess and communicate risks based on product complexity, resource and/or timeline constraints
- Use continuous integration and delivery concepts to deliver code to production
- Work closely with development, product managers and support
- Ensure projects are completed on time and according to quality standards
- Ensure projects are completed according to product specifications and are properly documented
- Facilitate communication upward and across the cross-functional project team including project status, justifications for variances and technical information
- Serve as the quality focal point for cross-functional partners on project status or other project information
- Measure and evaluate test progress including results of development test efforts (unit tests)
- Manage personnel activities of staff (i.e., hire, train, appraise, set goals, reward, motivate, discipline, writes performance reviews, recommend termination as necessary)
- Minimum of 3 years of experience in managing technical Quality Engineering teams
- Familiarity with advanced software/testing methodologies such as TDD
- Familiarity with Performance Testing
- Experience working in cloud computing
2
Quality Engineering Manager Resume Examples & Samples
- Lead the automation team for Cloud Security at VMW
- Analyzes current architecture and test platforms to formulate a vision for growth and expansion
- Provide leadership, guidance, training and mentoring to project teams and quality test engineers for the implementation of testing automation processes and best practices as needed
3
Quality Engineering Manager Resume Examples & Samples
- 10+ years of software engineering in organizations of platform/infrastructure software R&D or enterprise IT department
- 5+ years in a platform/infrastructure architect, technical manager/lead or Quality engineering manager role
- Passion for innovation in platform & infrastructure solution; passion for delighting Engineers & end-user experience
- Experience of large scale applications using virtualization & cloud, middle-ware; OOAD, Design Pattern, SOA, micro-services
- Technically hands-on in Core JAVA; Experienced in developing and managing test framework in Core JAVA for big enterprise products
- Knowledge on scripting using Ruby or Python is highly desirable
- Mentoring the team technically and professionally; Resolve the technical issues of internal and external consumers of the products
- Experience in planning various test activities of the team including development of various matrices to measure the quality
- Experience in a multi-function, matrix organization and remotely managed environment
- Working knowledge on VMware products especially ESX is a big plus
- Bachelor/Masters degree in computer science/Engineering with good academic record
4
Advanced Quality Engineering Manager Resume Examples & Samples
- Functions as the leader/manager for Advanced Quality Engineers. Ensures quality issues are resolved prior to launch of product (ensure mature quality at launch)
- Interviews, hires, and trains employees; plans, assigns, and directs work; conducts performance appraisals, coaches and mentors employees; rewards and disciplines as well as resolves employee complaints
- Prepares and presents technical, program information to the management team
- Ensures Advanced Product Quality Planning and Quality-related Global Program Management System process steps are being properly and thoroughly executed by Advanced Quality Engineers
- Evaluates Quality-related Global Program Management System program deliverables for effectiveness
- Represents Advanced Quality Engineering group in program reviews
- Track and maintain data analysis of key metrics and performance data as it relates to Advanced Product Quality Planning and Global Program Management System process steps
- Minimum five (5) years of work experience required in Manufacturing/Quality environment; with managerial experience required
- Certified Quality Engineer and/or Certified Six Sigma Black Belt is preferred
- High level of analytical ability; comprehensive understanding of Advanced Quality Planning and Production Part Approval Processes (PPAP) processes
- Intermediate or Advanced knowledge of Geometric Dimensioning &Tolerance
- Solid understanding of assembly and machining processes
5
Quality Engineering Manager Resume Examples & Samples
- Facilitate quality assurance testing for large-scale OTT platform, supporting services, tools, and client devices
- Serve as leader and mentor for developers and QA/QE team to improve process, efficiency, and quality
- Support and optimize continuous integration and production deployment processes
- Support and inform release cadence
- Work closely with teams to create test plans for upcoming features, develop automated test cases, and achieve a high level of code coverage
- Identify opportunities for improved software development lifecycle as a champion for quality across the organization
- Perform and oversee final checks for releases to production; validate and sign off on complex test plans
- Create documentation of processes, systems, and framework architectures
- Break applications in ways the developers never thought about
6
Healthcare Regional Quality & Engineering Manager Resume Examples & Samples
- Subject Matter Expert (SME) with a comprehensive understanding of the CMS Conditions of Participation and AHJ methodology
- Collaborates with the Account Director, Account Leadership Team and Facility Directors in the development of protocols and processes (SOP’s) associated Quality Standards and all other applicable Regulatory Agencies
- Develops and implements standardized processes for conducting compliance audits at each Hospital to determine Operational Readiness/Preparedness
- Utilizes field audit data/information to prepare specific action/improvement plans for each Hospital/Site
- Serves as quality and compliance liaison between Jones Lang LaSalle and Client
- Maintains working knowledge and ensures compliance with the Master Services Agreement (MSA) and any other relevant amendments or appendices which guide Jones Lang LaSalle’s relationship with Client
- Advises Hospital Safety Committee(s), Infection Control Committee(s), Quality Committee(s), Site Environmental Rounds, Documentation Reviews, Fire / Life Safety inspections and Statement of Condition reviews and audits
- Provides Account Wide education to Jones Lang LaSalle staff on applicable regulatory processes and procedures while also communicating literature-based ideas with regard to effective quality/compliance strategies
- Determines the degree of compliance with applicable standards, as directed by Jones Lang LaSalle management, specifically in the areas of NFPA101 Life Safety Code-SOC/PFI/ILSM, Safety Management, Security Management, Bio-Hazardous Waste and Hazardous Materials Management and Waste
- Tracks, trends and recommends action plans with regard to KPI/SLA below standard performance (MSA Driven)
- Develop in partnership with the client and Jones Lang LaSalle Account Leadership team reporting tools and metrics specific to established KPIs, SLAs for tracking monthly, quarterly and annual outcomes/results specific to MSA contractual requirements
- Support building operations through a highly integrated facilities management and engineering team to assure high infrastructure availability and client satisfaction
- Ensure that communication with the engineering and facilities management staff is effective and thorough
- Provide Subject Matter Expertise to the region and account to support improvements in reliability, service delivery and problem management as required
- Maintain and support a Critical Environment Management program reflecting client requirements and industry best practices
- Developing and instituting consistent maintenance management practices across the facility portfolio
- Implementation and management of the computerized maintenance management systems (Corrigo, TMS, 360)in accordance with JLL and client expectations
- Overseeing use of consistent maintenance management key performance indicator reporting
- Identify risks to client facilities and eliminate downtime
- Administer technical skills assessments and technical training program of facility engineering personnel
- Develop training programs based on needs gathered through skills assessments
- Establish self as the internal “go-to” for Chief Engineers needing support. Rely on Technical services/Engineering Services, outside contractors, consultants or internal networking for technical support
- Administer/manage the JLL Engineering Services Compliance Program
- Conduct all activities with a focus on cost savings and increase in reliability. Research and implement innovative cost reduction programs
- Contribute to and implement a comprehensive environmental health and safety program, including safety training, OSHA compliance, MSDS/SDS tracking, and vendor pre-qualification
- Administer compliance with and reporting of applicable environmental health and safety programs
- BS degree required in an Engineering Discipline
- Five years of hospital experience in Plant Operations and/or Safety Management
- Five years of experience in personnel and team management
- Experience in Hospital systems with multiple hospital locations in several states (Preferred)
- Working Knowledge of Joint Commission Environment of Care Standards (required) to also include but not limited to Safety Code (NFPA101)
- Previous Experience as a Compliance Surveyor/Auditor/SME (Preferred)
- Participation in CMS validation surveys
- Proficient in Microsoft Office Suite of products, strong writing skills
- Strong analytical, organizational, and coordination skills required
- Demonstrated communication skills (oral and written) required
- Customer service orientation and strong presentation skills to internal and external parties required
- Quality Management Training/Certification (i.e. Six Sigma Green Belt/Black Belt)
7
Senior Quality Engineering Manager Resume Examples & Samples
- Be an expert in advanced quality methods and protocol
- Understand detailed implications of decisions and recommendations and be able to communicate recommended solutions to the product development team, all the way up through the executive leadership of the company
- Align cross-functionally, influencing a broad spectrum of stakeholders to deliver on the quality policy
- BSME/BSIE/BSEE or related Engineering degree
- 3+ years of experience with statistical tools
- Masters Degree with either MSME/MSIE/MSEE
- Understanding of technology, at the system and commodity level as well as software and usability
- Ability to work with and influence others
8
Quality Engineering Manager Resume Examples & Samples
- Understand the technology and functionality of consumer electronic products, and be able to assess the risk to a negative customer experience, so that it can be prevented during development
- Lead cross-functional teams in Design for Quality initiatives
- Utilize your comprehensive knowledge of standards, related disciplines, company strategy and goals, to ensure a positive customer experience
- Deliver solutions to complex problems through in-depth data analysis and forensics by using methodical approaches, along with experience, innovation and judgment to make decisions that may be based on partial information
- Create standards around which others will operate and build consensus
- Determine specific quality related functional milestones during NPI
- 7+ years of experience in an engineering and/or quality role
9
Senior Quality Engineering Manager Resume Examples & Samples
- Partners with Engineering, Operations, Service, Design Assurance, Quality Engineering and Quality Control to develop and implement processes, procedures, tools and trainings related to the following
- Skilled in test plan development and root cause failure analysis
- Familiar with reliability analysis and test methods and test method validation
- Experience with 21 CFR Part 820 / ISO 13485 compliant Quality Management Systems
- Experience hosting, supporting and/or managing third party audits (e.g. FDA, Notified Bodies, etc.)
- Working knowledge of IEC60601, IEC62366, EN62304
- Ability to effectively manage personnel and projects
- Ability to effectively work on project teams
- Ability to appropriately assess written design and device documentation as the principle advocate for compliance
- Excellent working knowledge of Design Control requirements
- Excellent working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Strong working knowledge with ISO 14971, experience in risk evaluation techniques, such as FMEA, fault tree analysis or HACCP
- 10+ years related experience in an FDA regulated industry with at least five years recent experience with complex electronic, electro-mechanical and/or software imaging medical devices
- 5+ years managing in a FDA regulated industry (either managing a design assurance team or quality assurance team with responsibilities for design controls)
- Excellent working knowledge of verification and validation in a regulated industry
10
Quality Engineering Manager Resume Examples & Samples
- Review and approve GMP documentation (Plans, protocols, procedures, CAPAs, deviations, etc.) specifically related to automation and MES systems (Delta V, Syncade, etc.)
- Provide support to multiple areas within the facility and may participate on projects across sites; requiring a good working knowledge of regulatory and Biogen Quality and Process systems as well as working knowledge of key automation/MES systems
- Work alongside senior members of the Quality Engineering Team, as well as other stakeholder groups, to revise/develop and implement complex Quality systems that can be global in scope
- Ensure adherence to internal procedures for facility/equipment and automation controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
- Performs Quality review and approval of change control documents and activities associated with change control
- Maintain knowledge of GAMP and applicable automation regulatory knowledge
- Approximately 10 years of experience in pharmaceutical or biotech manufacturing environment
- Previous experience within Quality Assurance, Validation, Automation/MES or related function strongly preferred
- Good communication skills in English, verbally and written
- Technically oriented role including experience of the validation of laboratory, production equipment automation and manufacturing execution systems (MES) and knowledge of production methodology involved in Biopharmaceutical production
- Self driven, demonstrated ownership and responsibility for work assignments. Value teamwork at all levels and performs work with an open mind inviting input and feedback from partners across the organization. Ability to work with colleagues across the organization. Ability to lead, support and motivate a Team including the prioritization
11
Quality Engineering Manager Resume Examples & Samples
- Bachelor's Degree in Mechanical or Electrical engineering, or other relevant field
- Proven track record of exceptional leadership skills
- Minimum of 10 years of experience in engineering, including 3 years in a manufacturing facility
- Minimum of 2 years of experience leading a team of engineers
12
Quality Engineering Manager Resume Examples & Samples
- A bachelor's degree and 7 years of professional work experience is required. 2 years management experience is required
- Experience with team leadership
- 2-5 years of management experience (software company preferred)
- 5+ years of Commercial Software or Quality Engineering experience
13
Quality Engineering Manager Resume Examples & Samples
- Work with other quality management, determine appropriate staff levels, schedules, and resources. Work with other managers to understand priorities and plan resource and time allocation accordingly
- Review and understand projects to assure comprehensive development plans to prepare for effective implementation
- Monitor and evaluate project and department progress and results
- Provide guidance and training to staff, assist direct reports in attaining career goals, motivate individuals to achieve results, and recruit and maintain a high quality staff
- Maintain and enhance cross-functional team relationships. Work with divisional customers, internal functions, and suppliers to accomplish quality and business objectives, and to maintain and improve the quality of communication
- Provide guidance and approval regarding quality strategies and approaches
- Develop and implement quality strategies and procedures to maintain and improve product and process quality, taking into account risk management, design control, process validation, and other quality tools
- Work with other Quality Management, develop budgets, and monitor spending
- Review, analyze, and approve protocols and reports, change requests, design transfer documents, and other quality documentation
- Understand and effectively participate in design control activities as applicable
- May serve as liaison between the company and various governmental agencies
- Interface with regulatory agencies and manage regulatory audits as required (FDA, ISO, PMDA, International)
- Excellent verbal and written communication skills with all levels of management and the other technical organization
- Knowledge of and experience with FDA, ISO, and international auditing
- Knowledge of risk management, design control, process validation, inspection, and auditing principles
- ASQ Quality Engineer, Quality Manger, and/or Six Sigma Black Belt certification desirable
- Customer-/Quality-focused
- Business results aligned
- Technically competent
- Ethical behavior
- Idea generator
- Facilitator
- Change agent
- Leader
- Motivator
- Sees the big picture
- Effective listener
- Perseveres despite obstacles
14
Quality Engineering Manager Resume Examples & Samples
- Approve IQ, OQ, PQ, TMV or Software Validation
- Generally requires 5-8 years related experience including 2-4 years specific experience in a management/supervisory role
- Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
- The ability to perform "hands on" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is high desired
- Excellent technical understanding of manufacturing equipment and processes is required
- Experience in supervising and directing the work of others is required
15
Product Quality Engineering Manager Resume Examples & Samples
- Provide training and leadership to the PQE team, enabling successful anticipation and proactive management of product quality, durability and reliability issues and improvement opportunities
- Provide direction for the Reliability Testing program, emphasizing relevance to realistic consumer use cases and alignment with Belkin’s risk tolerance, to focus upon preventing and addressing quality, durability and reliability issues and driving key lessons learned into the NPI process
- Incorporate competitive product benchmark testing into Reliability Testing program
- Ensure the PQE team works closely with the New Product Development teams and suppliers to define and execute quality goals, including identification, definition, implementation and tracking of Critical-to-Quality (CTQ) attributes and acceptance criteria
- Implement appropriate quality analytics tools to validate resolution of any issues to ensure quality goals are met and sustainable
- Drive PQE’s Early (RMA) Failure Warning program, where early product returns are analyzed, leading to closed loop corrective action and implementation of appropriate permanent solutions
- Estimate impact of failures on return and field failure rates to drive informed and appropriate technical and business decisions
- Spearhead and assist PQEs with the execution of the FMEA (Failure Mode and Effect Analysis) program for new designs
- Develop and review special process development plans and provide technical guidance documentation for new products
- Drive identification and implementation of effective solutions to business/quality problems across the organization, including supplier, NPI and initial launch product quality
- Participate directly and ensure PQE team participation in supplier quality management assessment and qualification of new partners relative to their impact upon new product introduction
- Articulate and effectively communicate quality-related issues in terms of risk and potential impact to our brand, financials, schedules and other business objectives
- BS in Engineering; BSEE, BSME or BSIE preferred
- At least 10 years of previous Quality Engineering experience required; consumer electronics experience highly desirable
- Experience in product design for quality and reliability, including electrical and mechanical components is required
- Familiar in implementing ISO 9001 Quality Management Systems; ISO Lead Assessor experience preferred
- Detailed oriented with strong presentation, communication and organizational skills
- Proactive, self-motivated personality with leadership skills required to drive ongoing quality improvements on a project as well as organizational level while working across a diverse group of departments and organizational levels
16
Quality Engineering Manager Resume Examples & Samples
- Provides leadership and direction for all members involved in Quality Systems support and coordinates the team’s efforts with other support areas
- Maintains contact with customers, suppliers, manufacturing, and support resources to ensure that Quality Assurance systems are meeting objectives and continuously improving
- Maintains appropriate level of staff support necessary to meet business goals and objectives. Monitors productivity of groups and individuals, recommends changes where desirable. Provides leadership and support to staff to assist employees’ with skill development. Develops team-based organization focused on goals and objectives
- Leads the effort to internalize quality systems that meet or exceed ISO9001/2000, ISO17025 and TS16949 Standards
- Promotes and reviews programs relating to safety, quality and productivity in the division and recommends changes where desirable. Performs regular workplace inspections and monitors compliance with all Health and Safety policies and procedures
- What is this equation used to calculate Cpk LSL = (“x bar” – LSL) / 3s ?
- What is the final phase of the APQP development process?
- What is the primary difference between Cpk and Ppk?
- Has a bachelor’s degree in engineering
- Has successfully lead and supervised quality engineering teams
- Minimum 5 years experiences as a direct customer contact for automotive OEM customers
17
Quality Engineering Manager Resume Examples & Samples
- Drive Quality Engineering (QE) and testing efforts within the Project Services team
- Analyze and assess current QE and testing processes, practices and procedures
- Collaborate with leadership to define and execute QE roadmaps and strategies
- Develop, document and implement best practices, processes, operational activities and procedures
- Establish and implement standards for documenting and communicating QE activities, testing activities and test results
- Ensure measurable improvement of software quality by identifying, developing and implementing innovative QE capabilities, strategies, approaches and services
- Define quality metrics and targets for assessment, measurement and continuous improvement of QE and testing effectiveness
- Define, implement and manage a Quality Engineering and testing framework
- Improve the efficiency, effectiveness and speed of Quality Engineering practices and testing activities through the identification and implementation of automated testing tools and procedures
- Partner with project managers, development managers, project members, operations and support resources to plan, coordinate, execute and report QE and testing activities associated with software development projects, enhancements and production support
- Initiate, plan, execute, manage and complete QE activities related to complex application and system implementation projects
- Create and maintain test strategies, plans, scenarios and cases
- Lead and manage test schedules, test environment management and configuration requirements
- Establish and administer entry/exit criteria associated with promoting code through testing and production environments
- Partner with business analysts to ensure requirements are met and accurately tested
- Recruit and manage QE department staff
18
Quality Engineering Manager Resume Examples & Samples
- Represent the Corporation, Division and Quality Department in a professional manner
- Manage an engineering staff to ensure proper implementation of the Quality Engineering duties and responsibilities
- Prepare and maintain department budget
- Prepare, maintain, and report allocations of Cost of Quality spending to Division COQ system
- Hire, train, develop, review, and manage exempt and non-exempt employees
- Provide Quality Engineering support to maintain the Division Product Stability Program
- Provide Quality Engineering support to assist in resolving quality issues that surface in the field
- Prepare and implement divisional policies relating to quality, project management, product/process development, design control regulations, etc
- Participate on Project Team as Quality Representative. Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development
- Provide support for Project Teams or Quality Department
- Create, review and approve Quality System Documents
- Create, review and approve Product Documents for products purchased, manufactured and/or distributed by BARD
- Create, review and approve Protocols, Process and Product Validations, Stability Protocols
- Create, Review and approve documents required for Design History File
- Create and Review Risk Assessments such as FMEA, FMECA or FTA
- Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans
- Perform Internal or Supplier Quality System Audits
- Ensure compliance to Corporate, Division and Department procedures
- Participate and have membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
- Technical support for complaint review and investigation
- Tracking and trending of Quality Indicators. Develop Quality indicators to enhance quality of products and business performance
- Interface with manufacturing facilities or other Division Facilities
- Serve as Independent QA Reviewer and Chairperson for Design Reviews
- Participate in worldwide business travel as required by the above duties and responsibilities
- Strong Verbal and written communication skills and presentation skills. Technical writing skills. Management skills. Budgeting skills. Computer skills Knowledge and understanding of Document Control practices. Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information. Comprehensive knowledge of quality systems and relationship to business. Has experience in writing protocols/validations and has fundamental knowledge of validation principles. Understands basic applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi. Ability to serve in leadership roles on projects or assignments. Comprehensive understanding of auditing principles and ability to perform as a lead auditor. Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies. Broad knowledge of manufacturing processes. Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience. Understands Fundamentals of Engineering Principles. Ability to effectively manage time. Ability to handle multiple task assignments. Ability to translate quality requirements into product specifications. Ability to interpret Regulations, Corporate, Division and Department Procedures
- Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology
- Able to take theoretical mathematics and apply to business problems
- Four (4) year Science, Engineering, Technology, or Business Degree
- Eight (8)+ years experience in a decision-making quality engineering position or equivalent quality related experience with at least 2 years in FDA Regulated Industry
- American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager
- Manufacturing environments
- May include visits to clinical sites or hospitals
19
Quality Engineering Manager Resume Examples & Samples
- Quality Engineer with the responsibility for Metrology department
- Analysis of data, CPK, gauging and measurement of product
- Reporting, fault finding and analysis of daily data to ensure we supply parts to customer requirements
- Gauge R&R
- SPC, control charts (Statistical analyses of results from capability studies and produce reports)
- Calibration management
- CMM and Gauge
- Liaison with Production Engineering and Programme Management during and following analysis to enable process development
- Co-ordination and participation in new gauge / check fixture measurement system analysis including calculations (R&R studies)
- Generate gauge / check fixture specification and agree with customer
- Presentation of dimensional results to customer during build status events or ongoing production
- Knowledge of quality standards Core Quality tools Inc TS16949
- To project a professional image of the company to customers / visitors
- To use the escalation procedure for any issues/concerns e.g. Quality / downtime
- ONC in engineering or relevant experience
- Manual gauging, Calibration, data analysis
- TS16949 and APQP process
- Ability to work on own initiative
- Good literacy & numeracy skills
- Strong attention span with a good eye for detail
- Must be prepared to travel
- Hold a valid UK driving licence
20
Quality Engineering Manager Resume Examples & Samples
- 3+ yrs experience managing a team of engineers in the software industry
- Knowledge of testing and experience creating test plans, writing test automation and qualifying software products
- Experience defining and implementing performance testing
- Technical proficiency in audio/video or graphics
- Demonstrated ability to work in a highly cross-functional environment
- Demonstrated ability to triage problems
- Familiarity with iOS, macOS, and Unix
- Ability to manage multiple tasks, prioritize work accordingly and meet deadlines
21
Quality Engineering Manager Resume Examples & Samples
- Manage Quality Engineering activities by providing leadership and direction in the development, implementation and monitoring of Quality Systems and Lean Manufacturing principles for mass production of injection-molded products
- Lead continuous improvement strategies in support of strategic Quality objectives
- Lead and manage activities required to prepare organization for ISO 9001 compliance and certification
- Participate and advance customer relationships to understand product requirements, establish product specifications and respond to quality concerns in a timely, comprehensive and professional manner
- Lead the development of databases, data analysis and comprehensive reports that play a significant role in confirming product quality and supporting continuous improvement initiatives
- Lead and coordinate the development of standard operating procedures (SOPs) and operator training materials including the proper use of inspection gages, interpretation of data and escalation protocols
- Lead and direct root cause analysis and identification of permanent corrective measures that drive efforts to continually improve product reliability and process capabilities
- Audit and collaborate with critical suppliers to development and maintain raw material specifications, material traceability and ongoing compliance standards
- Work in partnership with Product Engineering to complete customer PPAP’s including the establishment of process flows, control plans and manufacturing process capabilities for new product introductions
22
Quality Engineering Manager Resume Examples & Samples
- A minimum of a Bachelor’s Degree is required, preferably in Engineering or related technical field
- A minimum of 8 years related experience is required
- Experience in a management/supervisory role (project management and co-op supervision is considered) is required. Strong mentoring, coaching and leadership skills are required
- An understanding of product life cycle is preferred. Experience in test method validation (MSA) is preferred
23
Quality Engineering Manager Resume Examples & Samples
- Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- Provides effective oversight of the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the product/system lifecycle
- Can Lead quality related problem solving and root cause analysis during design and manufacturing
- Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
- Bachelors/Masters Degree in engineering (EE, ME, Industrial etc..) 10+ years exp, of which- 3-+ are in functional/team management/leadership
- ASQ certification as Certified Quality Engineer or DFSS Green Belt / Black Belt
- 5+ years’ experience in FDA regulated Medical Device
24
Advanced Quality Engineering Manager Resume Examples & Samples
- Active participation in process analysis, design reviews, advanced product quality planning, new product/process validation and Safe Launch
- Serve as Voice of the Customer to the internal organization
- Strong background with automotive and high volume manufacturing
- Active involvement with Customers to capture Voice of customer in TE’s manufacturing process to drive flawless execution of new project launches
- Work with cross functional teams to drive successful and flawless execution
- Coordinate Customer Concern Resolutions
- Lead a team of Project Engineering Managers and Advanced Quality Engineers in U.S. and Mexico
- Use of advanced risk analysis tools to understand internal and external risk
- Develop risk mitigation plans to apprise leadership and deliver mature product lines to manufacturing plants
- Lead, coach and mentor staff in a constant and consistent manner to unleash people to realize their maximum potential
- Successful candidate will have significant experience with Tier 1 automotive manufacturing background
- Strategic thinking with a keen and constant desire for continuous improvement of business processes is a must
- Drive continuous improvement initiatives from a process and systemic perspective to improve Cost of Poor Quality and response time to customers
- Challenge status-quo and develop teams to own and drive continuous improvement mentality
- Innovate manufacturing and business processes to achieve exceptional customer experience that become global benchmarks or best practices
- Plan, develop and improve quality infrastructure (people, process and systems)
- BS degree in Engineering from an accredited university
- Masters in Engineering or MBA preferred
- Certified in TS-16949 requirements
- Lean Six Sigma Black Belt or advanced knowledge and use of Shainin tools preferred
- Prior experience or background in Manufacturing Engineering / Product Engineering is strongly desired
- Heavy Experience with new program launches in Tier 1 / OEM environment
- Good working knowledge of automotive control systems
- Good working knowledge of automated manufacturing processes and End-of-line testers
- Good working knowledge of Digital Factory Systems
- Hands on experience with all tools of TS16949 especially APQP, PPAP, Root Cause Analysis
- Working Knowledge of SPC, Capability Analysis, Gage R&R and Statistical Techniques
- Experience with Minitab or other statistical software strongly desirable
- A strong sense of urgency and ability to multi-task in a very fast paced global business environment is required
- Challenge status-quo and drive innovation
- Proficiency in working with Microsoft Office tools and other software products
- Excellent verbal and written communication skills and have project management capabilities
- Must be able to lead, motivate and develop engineering resources within a matrix organization
- Considered as a thought process leader
- Candidate should be self-directed individual possessing managerial courage and business acumen
- Travel within US, Mexico and other international locations as required
25
Quality Engineering Manager Resume Examples & Samples
- Provide Quality Engineering leadership in direct support of medical device manufacturing, including
- 4 year degree; industry certification or advanced degree preferred
- Class III or II medical device experience
- 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired
- 3-5 years in a supervisory/leadership role
- Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment
- Ability to travel internationally to support international manufacturing sites
- Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC)
- Demonstrated and impactful strong project management and people leadership skills required
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Ability to travel approximately 25%, including internationally
- Willingness to relocate and be open to global mobility assignments
- Six Sigma Black Belt strongly preferred
- ASQ Certified Quality Engineer strongly preferred
- Experience with hardware/capital systems
26
Quality Engineering Manager Resume Examples & Samples
- Partner with team leaders to implement and support an innovative engineering structure focused on increased technical collaboration and efficiency
- Conduct regular one-on-one sessions with quality engineers to review engagement, team dynamics, learning and development, performance, and workload
- Coach and mentor quality engineers of various experience and backgrounds, setting benchmarks for development of technical competencies, collaboration and teamwork, and role and career goals
- Collaborate with other managers and leaders in conducting year-end, and mid-year performance reviews in accordance with WTW policy and values
- Identify deficiencies in the collective technical expertise of the engineering department, then recommend and implement solutions
- Guide the establishment, implementation, and measurement of quality assurance standards and best practices
- Facilitate learning through workshops, conferences, meetings, and team off-sites, leveraging WTW learning and development modules
- Remain up to date with the latest software quality assurance tools, trends, practices and technologies
- Contribute to building an environment where continuous learning and improvement of the engineering team is in focus
- Promote a strong engineering culture predicated on the ideals of ownership and accountability
27
Customer Quality Engineering Manager Resume Examples & Samples
- BS, Electrical Engineering, MS/MBA preferred
- 5 years of experience in a Technical Engineering/Quality Engineering role for a Technology/High Tech Company
- 5 years customer management experience minimum
- 5 years experience of successfully partnering and problem solving with inter-departmental partners and customers
- ASQ Quality Engineer and auditor certification, along with six sigma black belt certification is highly preferred
- Experience in driving initiatives such as ISO 9001:2008, LEAN, Six sigma, 5S, and TQM
- Excellent computer and data mining skills with a strong background in SPC control methods (JMP a plus)
- Good working knowledge of Quality Tools – 8D & DOE at a minimum
- Experience and proven success working with contract manufacturing models. Proven ability to drive improvements within those organizations
- Effective and efficient problem solving skills with the ability to multi-task and change course as necessary for the business
- Excellent written/verbal and data presentational communication skills. Capability to articulate and communicate issues, responses and resolutions, etc
- History of collaboration and teamwork
- Ability to manage issues in different time zones worldwide
- Travel is approximately15-20%
28
Quality Engineering Manager Resume Examples & Samples
- Lead the end to end ownership of a Quality Engineering (QE/QA) team, including setting the technical vision for developing test frameworks and automation for our systems
- Build and manage SDETs and STEs that are responsible for developing and maintaining software for testing our product
- Be a champion of quality and operational excellence: establish team metrics for measurement of quality and operational excellence and a consistent, regular process for assessment and improvement
- Show strong business and technical judgment that will accelerate time to market of releases, while incrementally moving our services towards the long term vision
- Be responsible for mentoring and developing engineers
- 2+ years professional coding experience in a programming language like Java, C#, or C++, knowledge of JavaScript and Python are a bonus
- 1+ years professional experience creating test automation frameworks and tools from scratch
- Proficiency with a broad range of data structures, algorithms, and design patterns; knowing when it is appropriate to use them (and when it is not)
- Presentation and written communication skills are essential, as is the ability to build partnerships across distributed offices
29
Quality Engineering Manager Resume Examples & Samples
- At least 8 years work experience in quality filed,
- At least 3 yrs. work experience in medical device industry or high regulated industry
- At least 3 yrs. experience as a people manager role, supervisor or manager. Etc
- Strong understanding of Quality System regulations (FDA, ISO13485)
- Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
- Rich experience and skills in leading/managing a team
- Well-developed organizational and analytical skills
- Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects and initiate team building
- Communicate globally, across teams and programs, from senior executives to administrative support personnel
- Good command of both English and Chinese Language is a MUST
30
Quality Engineering Manager Resume Examples & Samples
- 5+ years managing a Quality Engineering team with emphasis in CI, Tools, Automation
- Provide examples of quality measurements with targeted goals and Metrics
- Excellent problem solving, critical thinking, and communication skills
- Experience with mobile platform systems
- Primary lead on at least three customer-facing features with year-long development cycles involving multiple engineering teams
- Provides regular updates to organization groups as well as VP-level management
31
Quality Engineering Manager Resume Examples & Samples
- Passion for driving quality into software products
- 5+ years experience in software development and Quality Engineering
- Proven track record of leading medium to large size teams focused on automation, building tools and quality assurance
- Be very hands-on in contributing to framework and test automation
- Experience in Java, scripting languages (perl, PHP, Python, etc). Linux platforms and relational databases
- Strong in analytical problem solving and looking beyond what’s obvious. Proven bug detection and regression skills
- Managed and led a team of quality engineers, and experience working with vendor resource
- Experience testing on Mac OS, iOS (mobile apps). Cloud based technologies a plus
- Experience reporting and tracking bugs & third-party issues
- Partner with development managers and other teams to organize testing responsibilities, and to drive strategic initiatives
32
Quality Engineering Manager Resume Examples & Samples
- Quality Policy and QMS: Support to manage the Quality Policy and Quality Management System requirements for procured and repaired products. Regularly review the Policy and QMS to assure compliance and customer needs are adequately being met and served. Identify opportunities to continuously improve processes, products, and systems and provide training, support and resources
- Supplier Quality Management: Support to establish and monitor quality standards for all products and services related to mobile devices. Proactively resolve and prevent product quality issues. Support to implement strong quality management and FMEA processes with each OEM to minimize the impact on customers and operations. Provide feedback to Terminal Management to affect purchasing decisions and Product Development to affect terminal acceptance decisions. Work closely with Product Development and Customer Care regarding customer impact due to quality issues and work with suppliers to resolve in a timely manner
- Continuous Improvement Projects: Drive a better product/service experience by influencing cross-functional process improvement, and through the proactive identification and authoring of business requirements to be driven into the next HW and SW maintenance release of a product or generational improvement. Participate and lead projects that help drive operational efficiencies and corporate strategies. For example, driving down mobile device Exchange Rates, Buyer’s Remorse Rates, No Trouble Found Rate, and Special Projects etc
- Supplier Qualification and Audit (internal, external) Programs: Support to establish requirements for evaluation and approval of new suppliers with Quality Engineers. Support to determine Quality Plans based on customer requirements, risk assessments, and past performance. Support to assure execution to regularly audit the suppliers (new and existing) on their capabilities, quality management, their supplier management, effectiveness of problem solving, metrics collection, metrics analysis and actions plans on a regular basis. Provide observations and recommendations to the team on the findings and the roadmap of activities that need to be conducted. Develop strong relationships with suppliers to enable open and proactive dialogue between the organizations. Review audit reports and action items to ensure closed loop feedback and escalate issues as needed. Drive all findings resolution and closure in Quality Center
- Technical:Must possess the technical expertise to understand both HW and SW issues and be able to communicate issues with supplier and technology vendors. It is imperative to be able to analyze product and process issues, collect and analyze data, identify root cause and drive to timely resolution. In addition, must be able to communicate the issue (both technical and non-technical) cross functionally to gain buy-in and feedback from stakeholders
- Product Qualification Processes: Support to establish quality inputs into Roadmap & Supplier selection/approval processes through New Product Introduction initiatives and frequent manufacturing line readiness reviews and repair audits
- Quality System Processes: Participate in Product Quality Reviews, Design For Serviceability Reviews, First Article Inspections, Early Warning Process (for Buyer’s Remorse and Advanced Warranty Exchanges, etc…) Ensure closed loop feedback to Product Development and OEMs to ensure generational improvements. Drive all issue resolution and closure in Quality Center
- Policy Projects:Support all customer facing programs (Example, Trade In - Trade Up, JUMP, Second
- Must have technical and/or working knowledge of consumer electronics. For example, hardware (PCB and component) and software testing experience
- Must be able to perform ISO and TL factory audits of OEMs and sub tier vendors
- Must have strong written and verbal communication skills in English
- Must have working knowledge and experience with Microsoft Programs (Excel, Project, Word, PowerPoint, Outlook and Sharepoint)
- Experience with ERP and Warehouse Management systems such as SAP and JDA preferred
33
Quality Engineering Manager Resume Examples & Samples
- Coordinates and executes Quality Engineering and Quality Control activities to maintain and improve product quality by executing inspection, measurement and test activities, partnering with Operations regarding production and process controls, leading process risk management activities, supporting product investigations, partnering with Product Development and Operations on design transfer of NPI projects and process validations and partnering with Quality Assurance regarding supplier performance and part qualifications
- Partners with Quality Assurance to ensure quality metrics (e.g. field, manufacturing and inspection) and key process indicators are identified, measured and action driven. Identifies unacceptable trends and applies suitable corrective action in order to meet strategic objectives
- Directs activities as well as sets goals and objectives for the Quality Engineering and Quality Control departments
- Educates Quality Engineering personnel in regards to quality engineering tools and their practical applications
- Educates Service, Operations and Quality Engineering personnel in regards to process failure mode and effects analysis, control plans, process and test method validation and their practical applications
- Leads the development and implementation of policies and procedures for production and process controls, inspection, measurement and test, verification and validation of processes and/or equipment
- Leads and/or participates in multi-departmental and multi-site teams to implement quality engineering initiatives
- Complies with all QSR, GMP and ISO 13485:2003 regulations and associated procedures
- Updates job knowledge by studying trends and developments in quality engineering management
- May include other duties as defined by the Sr. Director, Quality Engineering
- Computer literate - able to use Microsoft Office programs, business systems and spreadsheet programs
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations
- Excellent interpersonal skills to interact with all levels of the company and oversight agencies
- Strong experience training and mentoring personnel
- Seven to ten years related experience in an FDA regulated industry with at least five years recent experience with complex electro-mechanical medical devices
- At least five years of managerial experience
- ASQ Certified Quality Engineer (preferred)
- Six Sigma Certification (preferred)
- Excellent working knowledge of medical device regulations (21CFR), ISO 13485:2003, ISO 14971:2012 and Medical Device Directive
- Excellent working knowledge of design controls, risk management, test method validation, software validation and process validation
- Excellent working knowledge of inspection, measurement and test techniques and processes
34
Quality Engineering Manager Resume Examples & Samples
- Oversee the Quality Management System in compliance with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485 and all other jurisdictions found underneath the MDSAP program
- Act as the site Management Representative for all third party inspections/ audits
- Conduct Management Review including: collecting and presenting all Inputs and delivering of documentation outputs as prescribed
- Participate as the Quality lead on software based design projects driving IEC 62304 compliance
- Assist in Validation and Verification activities pertaining to design and sustaining Engineering projects
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable regulations/standards
- Participate in Risk Management activities in conjunction with ISO 14971 assuring compliance and risk reduction is maintained throughout the products lifecycle
- Manage all CAPA, Internal Audit, Training, and Document Control activities specific to the software products developed in Sunnyvale
- Maintain site Key performance indicator data and driving improvement efforts when required
- Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities
- Minimum 5 years related Quality experience with at least 2 years managing direct reports
- Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2003/2016, Canadian MDR, and Medical Device Directive
- Experience with test methods and standards for the design, verification, and validation of medical device products
- Strong analytical skills including trend and statistical analysis, interpersonal, and management skills
35
Quality Engineering Manager Resume Examples & Samples
- 60% - Manage the day-to-day activities of the Quality Engineering group. This may include, but is not limited to, activities such as providing direction to subordinates by assigning Quality Engineers to support programs and interface with other Aerojet Rocketdyne departments, establish contractual priorities and assign personnel to meet those requirements. Maintain department’s fiscal and commitment objectives by participating in planning meetings. Perform personnel performance evaluations in accordance with Company policies and procedures
- 20% - Act a lead or support Quality Engineers on programs as required. Determine quality flow-down requirements, derived from customer requirements, to suppliers and internally. Communicate product and quality requirements to Quality Engineers and other functional organizations. Support procured hardware documentation and acceptance review activities including EIDP reviews. Work problem resolutions including the initiation and closure of root cause and corrective/preventative action. Support proposal activities as requested
- 20% - Lead or participate in continuous improvement projects and initiatives that drive improvement in key performance metrics. Respond to negative trends in performance data through the use of continuous improvement tools. Drive the use of process variation reduction activities on the manufacturing floor
- Prefer experience in functional management with proven leadership in Quality Assurance or related discipline
- Electromechanical manufacturing and test experience required (preferably with aerospace industry emphasis)
- Requires a working knowledge of common quality standards (ISO-9001and AS-9100) and typical aerospace processes (machining, welding, soldering, MRB, etc)
- Demonstrated experience in the leadership of continuous improvement tools (e.g. Lean, 6S, DFSS, root cause analysis, process mapping) needed
- Should have experience in new product development in a multi-functional team environment
- Must demonstrate excellent writing and verbal skills, and an ability to mentor and increase the effectiveness and productivity of employees
- Must have experience partnering with other business organizations including Finance, Engineering, Program Management and Operations
- Advanced degree in Business or Engineering is a plus
36
Product Excellence Quality Engineering Manager Resume Examples & Samples
- Bachelor’s Degree in a S.T.E.M. field
- A minimum of 10 years of experience in Aerospace, and/or Manufacturing industries
- A minimum of 3 years of management or leadership experience
- Active SSBI must be held and maintained
- Experience with reading and interpreting wiring schematics, blueprints, GD&T, and use of basic inspection equipment
- M.S. degree or MBA is preferred
- CAM/IPT experience is preferred
37
Quality Engineering Manager Resume Examples & Samples
- 5+ years technical management experience of software engineering teams that have successfully delivered customer-driven software products with highest quality
- Passion for being at the leading edge of technology with 10+ years of hands on software development and/or testing/production experience
- 5+ years of hands on RESTful/SOA services development using Java
- 5+ years of delivery experience with Agile software development methodologies
- Proven experience in delivering highly scalable solutions, automation & CI solutions with open source tools
- Adept at articulating the strategy and drive change with strong technical & business acumen
- Solid understanding of cutting-edge technologies, industry wide testing tools/services
- Ability to think and act strategically for all stakeholders; Possesses strong verbal, written communication & presentation skills
- Experience with AI/Statistics/ML is a plus
- Master’s degree in Computer Science or any Engineering Discipline
38
Senior Design Quality Engineering Manager Resume Examples & Samples
- Lead Quality team of 2 or more Design Quality Engineers
- Lead Quality for the next generation product launch while ensuring Design Controls are met
- Lead Quality for current generation product, including remediation and base business support
- Support Supplier Quality in qualification and compliance of the existing supply base and any supplier transitions
- Lead implementation of DePuy Synthes Spine design controls and other related processes
- Apply advanced knowledge in regulations and external standards to guide and coach process owners in the development of compliant processes and procedures
- Participate in the site and department strategic planning, metrics, and capacity planning
- Bachelor’s Degree in an engineering discipline
- 8+ years’ experience in Quality Engineering, preferably Design Quality Engineering (Design Controls)
- 5+ years in a Quality Leadership role
- Highly motivated with ability to work independently
39
Quality Engineering Manager Resume Examples & Samples
- Bachelors or Masters degree in engineering or a related scientific discipline
- Minimum 8 years experience in the Medical Device Industry (implantable experience preferred)
- Minimum of 3 years proven track record in supervisory experience
- Demonstrated organizational and communication skills. Must possess strong leadership and analytical skills with team-focused attitude
- Experience with device packaging and sterilization validation preferred
- ASQ certification desired
- Demonstrated knowledge of FDA regulations, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other national and international regulations and standards
40
Quality Engineering Manager Resume Examples & Samples
- Lead, monitor and deliver the team of Industrial Engineers to support the design, implementation and improvement of quality services for Ops and other business units
- Plan, develop and implement initiatives to improve customer journey through CRSSC supported programs and sharing of best practices across supported programs and other LOBs that are customer-facing in SSC
- Develop departmental goals and objectives consistent with strategic plans for SSCCR Quality department
- Work closely with other Quality Front Line Managers in order to implement standards and better practices across Call Center, Back office and project-based programs in order to have a calibrated level of service for all LOBs through the support of the Process and Quality Engineering Team
- Identify and develop process and quality assessment opportunities in order to provide improvement in productivity and quality
- Develop, collect, analyze, and report quality statistics and measures to determine process capability, sustain process control, support problem resolution, and promote continuous improvement. Initiate and lead improvement efforts as appropriate in conjunction with CRSSC Process Improvement team
- Work closely with SSC Training department in order to implement continuous improvement cycle through coordination of systematic actions between Quality – Training and Ops for new programs
- Maintain an assertive communication and keep day to day effective contact with Business Owners for Quality purposes
- Create/Implement/Analyze regular reports to communicate project progress to Ops LT and business Owners
- Provide succession planning by preparing individuals for future advancement opportunities through the use of regular mentoring activities and opportunities to act in leadership capacity
41
Quality Engineering Manager Resume Examples & Samples
- 3+ years of Manufacturing experience
- Ceramics and Injection Molding experience
- Previous experience with Six Sigma Black Belt
42
Quality Engineering Manager Resume Examples & Samples
- Perform detailed project planning and project management support including work breakdown structure, estimates, status reporting and project closeout specific to test or automation initiatives
- Project level test strategy / plan artifacts that support the implementation of shift-left testing and white box/gray box testing objectives such as: component / service level testing, service virtualization, data conversion / system integration testing, continuous build release testing and version control, pairwise / orthogonal array and control flow testing
- Analyze system / application architecture to identify additional testing entry points to reduce project risk
- Perform complex analysis of business / technical requirements and specifications
- Manages And Assists With The Development / Execution Of Varying Types Of Complex Test Cases i.e., service level, component, functional, regression, automation, mobile, and end-to-end, etc
- Lead the implementation of risk based testing to align the testing effort with business risks / complexities
- Actively manages testing project risks and communicates mitigation options to business / Technology stakeholders
- Champion automation initiatives including application-level and End to end to achieve business process automation
43
Quality Engineering Manager Resume Examples & Samples
- To lead the Q.E. Department in determining product grade and defect origin
- Work on projects and assignments as required by the Plant Manager and/or plant and corporate management
- Work with company yarn vendors as well as outside yarn vendors to identify and correct yarn related problems
- Work closely with Financial Services, Sales Reps Customer Service and customers regarding quality problems
- Work with department heads with regards to quality improvement and to assist in solutions to quality related problems
- Research claims and bring to plant management's attention problems in this area
- Analyze product testing and keep management informed of product performance
- Participate in quality audits
- Attend new product reviews & CDT meetings
- Attend MTR reviews
- Manage, monitor, evaluate, and coordinate Shaw Management Systems (SMS)
- Reports to Plant Manager
- Some travel required
- Influence Others
- Demonstrate Customer Orientation
- Coach and Support
- Delegates Authority
44
Software Quality Engineering Manager Resume Examples & Samples
- 10+ years experience in software development and/or quality engineering (Black box testing, white box test automation, and system level testing)
- 5+ years experience managing topnotch software engineers
- 5+ years experience developing or testing large scale customer facing internet systems in an agile environment
- Java rockstar with good scripting skills in at least one common scripting language (Python, Shell, Perl)
- Strong background in designing or extending existing test frameworks; JUnit, TestNg
- Strong experience with RESTful web services, SQL, Jenkins, Maven, GIT/SVN
- Good understanding of application security; authentication, authorization, cryptography, etc
- Strong understanding of performance testing concepts and tools, with the ability to positively influence architecture and design decisions
- Ability to clearly communicate within the team and cross-functionally
- Ability to act as technical leader, evangelist, mentor and trainer for senior as well as junior team members
- Experience increasing production uptime and test coverage through process and automation
- Track record of reducing customer impacting defects
45
Senior Quality Engineering Manager Resume Examples & Samples
- Maintains a thorough understanding of regulations and guidelines to assure compliance with corporate policies, ISO 13485, MDD/MDR, MDSAP, CMDR(CMDCAS), FDA’s QSRs and other quality requirements, regulations, and standards
- Partner with the Manufacturing/Operations, R&D, supply chain, and other functions to ensure quality assurance and engineering methods drive the highest quality products and processes from development through manufacturing in accordance with applicable requirements
- Strong relationships and alignment with Manufacturing Operations, Complaint Evaluation Teams, R&D and New Product Development organizations will be required to create an effective quality team
- Ensure effective and robust quality of manufacturing processes & product
- Manage the organization, lead efforts to understand and provide the information that will be useful to the business entity and support a closed-loop corrective action system directly related to product performance
- Collaborate with site management team in development, identification, prioritization, and execution of goals, objectives and activities
- Demonstrate data-driven and engineering based decision making that is based on both driving business objectives and product quality improvements
- Assesses effectiveness of systems with respect to all relevant regulations and requirements
- Manage and operate effectively in a highly matrixed organization while fully supporting cross-functional initiatives in the area of quality
- Effectively recruit, retain, grow, and manage organizational talent. Develop effective succession plan
- Knowledge of quality standards per ISO 13485, MDD/MDR, MDSAP, CMDR, and FDA 21 CFR 820 applicable standards
- Knowledge and understanding of the risk management process and requirements of ISO 14971
- Six Sigma Black Belt and Lean Sigma certification and experience
- Demonstration of an ability to develop partnerships and inter-organization influence skills. Complex department and personnel management experience
- Advanced degree in a related technical discipline
- Knowledge of cardiology and the medical device business
- Demonstration of a willingness and ability to institute change
- Proven talent management and leadership skills including influence management
46
Software Quality Engineering Manager Resume Examples & Samples
- Experience supervising staff and making technical and resource decisions
- Experience providing work direction and coaching for software quality teams
- Able to evaluate employee performance and establish a path to success
- Able to create a climate of collaboration and teamwork in order to build trusted relationships amongst team members and coworkers
- Able to adapt quickly to situational changes and bring the team through changes with minimal disruption
- Hands on experience working on test automation framework and creating automated tests
- Hands-on experience using Python, REST APIs, Selenium, or other frameworks/scripting languages
- Solid understanding of general software development lifecycle and methodologies, especially Agile and Scrum
- Understanding and experience with CI & CD practices like automated tests, builds, and deployments
- Demonstrated history of staying current on best practices in technology
- Excellent problem solving and communication skills, along with a strong work ethic
- Education & Experience Requirements
- A Bachelor’s Degree in Computer Science, Software Engineering, or related field
- 3-5 years of directly managing, leading, and working closely with software quality and automation engineers
47
Quality Engineering Manager Resume Examples & Samples
- Provides overall direction and oversight for the Quality Engineering team in the development, maintenance, and compliance of Quality Systems directly related to manufacturing and packaging operations
- Manages the oversight of non-conformance investigations and implementation of corrective and preventive actions while assuring there are adequate product and process controls in place for identified CTQs
- Performs evaluations of process quality and performance attributes to identify continuous improvement initiatives related to Quality Systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products
- Actively participates in and contributes to routine engineering and manufacturing-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc
- Provide a source of consistent quality oversite in regards to the engineering lifecyle and change control. This includes; proper matrixed validation approach, attribute inspections, exception handling, proper order of operations, timely closure, appropriate validation paths, reviews of holistic validation packages
- Hire, train, coach, and evaluate associates
- Help create and maintain organization and structure within the department
- Plan/assign duties, tasks according to their KSAs (Knowledge, Skills, and Abilities), so that work assignments are carried out timely and effectively
- Evaluate the performance of associates, and celebrate successes
- Provide regular encouragement and feedback, both formal and informal
- Assess the KSAs of individual associates and of the entire team. Ensure training plans and development activities grow KSAs of individual associates, and the overall capability of the team
- Be attentive to employee needs and concerns. Resolve complaints involving individuals or multiple associates
- Collaborate with HR to correct performance and behavior problems through counseling and disciplinary action
- Act as a role model for company values and behaviors
- Adapt schedule to flexible work hours
- Acts as a coach for the technical members of the quality engineering department to maximize individuals’ technical abilities and creativity
- Mentor Automation Engineers and Validation Scientists, and Contractors on change control procedures and best practice
- Bachelor’s Degree in a scientific technical discipline (preferable engineering or computer science)
- 7+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, audit experience, Lean Six Sigma, computerized system knowledge, product and process validation, trending, and change control
- 5+years leading people at various levels and coordinating cross-functional teams
- Microsoft Office Suite with advanced Excel charting experience and statistical analysis capability
- Proven problem solving skills, and ability to meet deadlines under pressure
- Well organized, with good time-management skills, ability to build rapport
- Understanding of GAMP 5
- Previous experience drafting/executing FAT, DQ, IOQ, PQ, VMP documents
- Previous experience in the definition of equipment qualification approach and SOPs
- Technical understanding of aseptic process, filling, packaging equipment
- Strong GMP Documentation Skills
- Above average understanding of Manufacturing / Production Principles
- Strong computer skills, including Microsoft Word, Excel, Power Point, and Project
