Quality Senior Engineer Job Description
Quality senior engineer
provides support in the way of development and evaluation of process capability, process control plans, analysis of out-of-control conditions, and process audits with the objective of improving the process performance and capability.
Quality Senior Engineer Duties & Responsibilities
To write an effective quality senior engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included quality senior engineer job description templates that you can modify and use.
Sample responsibilities for this position include:
Apply statistical process control (SPC) methods to evaluate current processes and process changes
Identify and implement effective quality control systems in the area of CAPA and non-conformances at the Medical Device / Pharma / EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Collaborate and support company-wide CAPA and non-conformance implementation and continuous improvement projects
Review, approve, verify effectiveness and report quality metrics on CAPAs
Ensure all site teams and External Manufacturing suppliers are compliant to all regulatory (US and International) and company requirements
Proactively investigate, identify and implement best-in-class Quality practices
Support quality disciplines, decisions, and practices
Assist EM QA functions, supply chain and R&D organizations in systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG / EM suppliers
Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies)
Directly support management team for activities related to Management Review, Complaint Review Board and Critical Action Committee
Quality Senior Engineer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Senior Engineer
List any licenses or certifications required by the position: ASQ, CQE, ISO, CQA, NASA, CQT, AS9100, ISO9001, UK, TS
Education for Quality Senior Engineer
Typically a job would require a certain level of education.
Employers hiring for the quality senior engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Technical, Science, Computer Science, Education, Manufacturing, Industrial, Medical, Mechanical Engineering, Management
Skills for Quality Senior Engineer
Desired skills for quality senior engineer include:
FMEA
Design assurance
Product testing methods
Understanding of QSR/ISO regulations
Are able to use optical comparators and CMMs
Blueprint reading and geometric dimensioning and tolerancing
Process capability
Process control
Statistics
Supporting department needs and capabilities
Desired experience for quality senior engineer includes:
Participate in External Audits and Internal Audits as needed
CQA-certified
Experience in electronic quality system modules, such as ComplianceWire, CATSWeb, Documentum, QlickView
Solid trackable industry experience in building enterprise products or UI components
Strong design background to develop UI and application wireframes
BS, MS or Ph.D degree in Computer Science or relevant equivalent experience
Quality Senior Engineer Examples
1
Quality Senior Engineer Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of quality senior engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior engineer
- Lead the development and maintenance of Master Validation Plans
- Participate in the CAPA process as required as an assignee or project team member
- Investigate escalated product complaints to root cause to ensure timely customer response and correction
- Monitor product and process performance metrics and acts upon trends (positive or negative)
- Lead MRB as a team member to ensure proper disposition of non-conformances
- Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling
- Conduct internal, vendor, and process audits to schedule
- Interface with suppliers to resolve Quality issues
- Develop and drive measurable Quality improvements relating to products, processes and services
- Serve as cross-functional team member to support new product development, procurement, manufacturing and servicing processes representing Quality Engineering discipline
Qualifications for quality senior engineer
- 6+ years of working experience in the Software industry as a Quality Engineer
- Requires a minimum of a Bachelor’s Degree in Engineering or field of science
- A minimum of 3 years relevant experience or a combination of equivalent education and relevant experience
- Knowledge of applicable regulatory, Corporate and/or Unit requirements
- Bachelors degree from an accredited institution in an Engineering, Mathematics or Physical Science discipline or equivalent years of directly related experience
- Minimum of 5 years of Quality Engineering experience or Manufacturing Process Engineering experience within the medical device or pharmaceutical industry
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Quality Senior Engineer Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality senior engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality senior engineer
- Provide expertise in the design, development, and implementation of suitable quality systems for new or existing products & processes
- Facilitate the design transfer process between corporate and plant environments
- Ensure compliance with applicable company policies and procedures such as Design Control, Validations, Sampling Plans, among others, in alignment with the regulations
- Conduct internal and external audits, in accordance to Quality System Regulations (QSR) and International Organization for Standardization (ISO) standards, assessments of Technical, Engineering, Operations, & Quality related areas
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints
- Provide guidance and oversight to Manufacturing Engineers and Technicians on procedural readiness execution and remediation
- Analyze scrap and rework data for significant issues
- Serves as the Quality lead and interface for products built at Brooks and at contract manufacturers
- Understands and maintains ISO 14001 certification
- Provides direction for the business component or an entire project and/or project team
Qualifications for quality senior engineer
- Minimum of 8 years related experience and/or training is required
- Ability to lead and manage cross-functional teams is desired
- Must have proven Project Management skills
- Proficiency in the use of Information Technology and applications is necessary
- Experience in Design Quality is desirable
- Bachelor’s Degree in Engineering or Science (Life Sciences, Physics, ME, EE, Industrial Technology)
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Quality Senior Engineer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality senior engineer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality senior engineer
- Monitor and report key field performance metrics (OBQ, WIRR, AFR, & MTBF) related to quality at MKS, P&RGS
- Maintain and analyze internal quality metrics (NCMR, SCRAP, & Rework) customer returns and failure rate data in depth
- Contribute and participate in the management oversight of the QMS
- Improve the performance and efficiency of overall quality by identifying adverse trends and developing subsequent action plans for issues
- Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product
- Manage the qualification of process controls, methods, and measurement systems
- Manage the internal audit program to ensure MKS P&RGS quality systems are in compliance with ISO9001(2015) and SSQA
- Manage the creation and revision of QMS documentation, training and periodic review
- Works closely with product management and customers to understand the customers’ experience particularly with respect to technical issues
- Providing technical assistance to the product management team in dealing with customers
Qualifications for quality senior engineer
- Exposure and experience in Agile development methodologies is a must
- Scrum Master or PMP Certification is a plus
- Must possess practical knowledge related to molded products and molding processes
- Possess basic PC skills, and have working knowledge of Microsoft Word, Excel, and Access
- Have practical knowledge and experience in statistical analysis, SPC, and Design of Experiments
- Must be able to properly use most inspection tools and test equipment
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Quality Senior Engineer Job Description
Job Description Example
Our company is looking for a quality senior engineer. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality senior engineer
- Lead and help implement Corrective Actions to improve Customer Product Quality
- Lead and help perform Root Cause Analysis and problem resolution to help improve and sustain product quality
- ISO 2008 transition to ISO 2015
- Write formal procedures to ensure compliance with ISO and other Quality Management System requirements
- Identify unfavorable quality trends and lead improvements to reduce Cost of Quality, improve yield or customer satisfaction
- Lead or participate on continuous improvement or corrective action teams as assigned
- Determine root cause of quality problems and lead implementation of effective corrective action
- Participate on cross-functional teams to qualify and approve new processes or new products
- Prepare detailed quality plans for large-scale projects to reduce risk of producing nonconformances
- Provide or coordinate required project quality related deliverables, such as, PPA’s, D/PFMEA, capability studies, statistical analysis, inspection plans, quality records and workmanship standards
Qualifications for quality senior engineer
- Ability to interface effectively with all departments and levels of the Triumph organization with customers
- The preferred candidate will be able to work a flexible schedule
- Is able to answer what this equation is used to calculate
- Can define what the final phase of the APQP development process is
- Is able to answer
- Experience building and executing automated scripts or experience with automation tools such as Appium, RSpec, Selenium, Cucumber
5
Quality Senior Engineer Job Description
Job Description Example
Our company is looking to fill the role of quality senior engineer. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality senior engineer
- Report on the performance of the quality system
- Participate in strategic planning and audits of internal and supplier quality systems
- Interface with various other departments and facilities within the company on quality related issues
- Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials
- The candidate will be responsible for building programs in Java, Java Script, C++ or Python to help ensure the delivery of quality trading system applications
- On-time execution of new component qualifications using PPAP process
- Liase with supplier for securing PPAP documents within agreed timeframe, registering in database & secure PPAP order placement
- Ensure PPAP are mature/correct & Collect Fit Form Function-test report confirming factory acceptance / site feedback
- Visit supplier / conduct FAI if needed (to be aligned with supplier responsible)
- Sign-off PSWs once requirements are fulfilled
Qualifications for quality senior engineer
- Background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device requirements is essential
- Able to generate and execute Qualification and Validation protocol and Quality Assurance Procedures
- Solves complex problem without any oversight and begins training others
- Leads small project team in the past
- Makes decision with supportive evidence
- Operates with minimal oversight for problems or assignments of reasonable difficulty