Principal Quality Engineer Job Description

Principal Quality Engineer Job Description

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Principal quality engineer provides overall leadership for ISO 9001 / 13485 / GMP compliance at locations supported.

Principal Quality Engineer Duties & Responsibilities

To write an effective principal quality engineer job description, begin by listing detailed duties, responsibilities and expectations. We have included principal quality engineer job description templates that you can modify and use.

Sample responsibilities for this position include:

Manage the testing, monitoring, and inspecting processes for Freestyle products
Assist with the evaluation and approval of software processes and procedures
Create and ensure compliance to best practices for quality assurance processes on products
Educates internal staff on customer experience concepts, value proposition, and processes
Review and provide guidance for proposed and existing changes through the formal change control process as it applies to validated processes, equipment and test methods
Lead in the development and execution of the strategy to design and implement test validation plans, inspection plans and monitoring plans (including data gathering) for large, high visibility projects
Ability to take ownership and accountability of quality, reliability and test plans
Ensure all required stakeholders are included in the strategy
Oversee the development and implementation of inspection and testing plans for Alpha, Beta and Production phases of product development
Work with Manufacturing to implement inspection and test requirements for production

Principal Quality Engineer Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Principal Quality Engineer

List any licenses or certifications required by the position: ASQ, ITIL, CQE, CRE, CSQE, NDI, III, CQA, DFSS, DMAIC

Education for Principal Quality Engineer

Typically a job would require a certain level of education.

Employers hiring for the principal quality engineer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Manufacturing, Technology, Math, Computer Science, Chemistry, Education, Industrial Engineering

Skills for Principal Quality Engineer

Desired skills for principal quality engineer include:

Calibration Systems
Engineering drawing interpretation
ISO 9001 standards
Inspection methodology and metrology
PR/MRB
Quality Systems
ISO 13485
GMP
Processes

Desired experience for principal quality engineer includes:

Participate with Engineering, Manufacturing and Procurement in new vendor review and qualification
Generate quality plans for all production products
Develop and maintain component qualification process
Perform failure analysis and maintain FA reports
Monitor and report on the progress of the department and all technical projects towards the Company's engineering goals and strategies
Monitor and report the progress of department and technical projects towards the organizations' engineering goals & strategies

Principal Quality Engineer Examples

1

Principal Quality Engineer Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of principal quality 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 principal quality engineer
  • This Principal Engineer will lead or support quality improvement initiatives across the J&J Enterprise in Development, Make or CLS as part of cross-segment functions/teams
  • This role will establish and sustain QE Best Practices and methods across the organization, drive cost reduction projects working in conjunction with other roles and functions, and review/analyze/improve the effectiveness of Quality improvement tools and programs
  • Additionally, this role will be responsible for the conducting benchmarking with external companies and internal sites to develop more effective methods for improving quality
  • Employ appropriate techniques and methods to successfully and independently execute/support material qualification projects
  • Lead/Assist with investigations related to raw materials/components
  • Assure that software nonconformances are documented and tracked to closure
  • Perform Performance & Load Testing (using Jmeter\Load Runner,…) and work on Continuous Integration tools like Dockers, Jenkins, Maven
  • Interact collaboratively with cross-functional teams in a global, matrix organization
  • Develops long term roadmap for Product VOC team
  • Champions the adoption of CEM strategies and tactics across the organization
Qualifications for principal quality engineer
  • Proven experience with supplier management
  • BS in engineering degree or related engineering field
  • Proficient in standard office tools, including Excel, Access, Word and Power Point
  • Applies intermediate understanding of regulatory requirements (cGMP, FDA, ISO, ) to support work with little or no supervision
  • Bachelor's degree in Science or Engineering and a minimum of 9 years experience working in a regulated, cGXP environment or Master's degree and a minimum of 6 years experience working in a regulated, cGXP environment
  • Demonstrated knowledge of cGXP regulations and guidance
2

Principal Quality Engineer Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of principal quality 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 principal quality engineer
  • Creates a brand identity that differentiates products and aligns with customer preferences
  • Leads in establishing CEM standards, policies, strategy and best practices
  • Designs CEM maintenance and improvement programs and presents to executive management
  • Refines and optimizes customer interactions within all channels to produce desired outcomes
  • Serves as customer advocate with senior management
  • Identify and overcome threats/dangers/barriers to successful implementations
  • Executes projects by interacting with customers, suppliers, and internal organizations to resolve design, development, production, and acceptance issues
  • Leads, directs, influences or coordinates the work of a major project, product or component with responsibility for overall department and project objectives, completion dates, and technical specifications
  • Develops and maintains quality work instruction standards for development and production work orders
  • Prepares necessary budgets, justifications and reports used to procure materials, develop customer proposals and quality plans, justify equipment modifications and upgrades, and procure acceptance equipment
Qualifications for principal quality engineer
  • Effectively operate within cross-functional teams
  • ASQC certification (engineering, auditing) strongly preferred
  • Able to interpret basic technical drawings including characteristics such as views, title blocks, dimensioning, GD&T symbols, Interpret specification requirements in relation to product and process characteristics
  • BS/MS in Engineering, Computer Science, or related Information Technology Field
  • Working knowledge of server, storage, and networking operation
  • Working with execution and sustaining quality teams to identify systemic quality issues and drive solutions to mitigate their effects on quality and customer experience
3

Principal Quality Engineer Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of principal quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for principal quality engineer
  • Designs and evaluates inspection requirements and make appropriate adjustments to processes and procedures
  • Demonstrate strong leadership qualities and embody Genzyme's core leadership principals
  • Develop integrated work plans and represent the Quality Assurance Technical Services team on integrated work teams
  • Participate in policy discussions and represent the Quality Assurance Technical Services team in policy discussions and issues impacting the direction of quality in the organization
  • Support the Quality Assurance review and approval of complex change controls, deviations/investigations, CAPAs, quality engineering, and continuous improvement to ensure that they meet the requirements of Genzyme standards and procedures, and are clearly and appropriately justified
  • Approve management activities in Quality Management systems (Trackwise)
  • Facilitate regulatory related CAPAs and audit responses
  • Generate and present metrics at the required frequency which drive accountability and delivery of targets
  • Lead the more formal risk assessments such as new product or transfer risk assessments
  • Work with project teams to determine the change control approach for complex projects
Qualifications for principal quality engineer
  • Ability to apply principles of root cause analysis and statistical analysis to determine common vs
  • Advanced Technical Training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, is required
  • Identifying and mitigating new risks to quality and customer experience introduced on next generation products
  • Provide Quality engineering requirements into product RFQ’s (Request for Quotation)
  • Bachelor’s degree in Engineering (any field of study) + 8 years of relevant work experience OR Master’s degree in Engineering + 6 years of relevant work experience
  • Ability to effectively communicate (oral and written) quality requirement rationale and build consensus
4

Principal Quality Engineer Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of principal quality 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 principal quality engineer
  • Oversee the review and approval of technical Validation documents as a team member of Quality Assurance Validation (QAV) and determine interrelated impacts to process and systems
  • Supplier selection and qualification process
  • Helps ensure that key users of the Quality Risk Management system are appropriately trained in regulations and SOPs
  • Propose and help implement modifications to the Risk Management Program to improve compliance, efficiency, and customer satisfaction
  • Responsible for managing the QA/HOS activities of 3-4 sites within the AMOC/AMSC network
  • Responsible for leading daily quality functions such as auditing, compliance, customer quality engineering
  • Assist in mitigating supplier quality issues and root cause corrective actions
  • Monitor quality aspects of the Annual Operating Plan and Strategy Deployment Plans and assure alignment to Aero Strategic goals
  • Serve as the point of contact and lead the quality discussions with leaders outside the site (primarily Vice President and Quality Director of AMOC/AMSC) on behalf of the site
  • Manage root cause and corrective action efforts and strategic quality initiatives
Qualifications for principal quality engineer
  • Must possess strong program management, relationship building, negotiation and influencing skills
  • BE/B.Tech or M.Tech in Computer Science or related field
  • Over 7+ years of experience in the Software product quality engineering and/or development
  • Must be an effective team player and mentor junior team members as well
  • Exposure to Salesforce Cloud environments and Azure platform is desirable
  • Deep understanding of Automation testing tools
5

Principal Quality Engineer Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of principal quality engineer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for principal quality engineer
  • Provide regular feedback and coaching for the site leadership teams regarding compliance issues
  • Drive execution of Lean principles and HOS initiatives
  • Monitor and coach supervisors and leaders on training compliance requirements and duty time roster requirement for the FAA, CAAC, EASA, DCMA and other applicable agencies
  • HOS understanding, strong change agent for Built-in Quality, APQP, Lean
  • Knowledge, skill and experience in collaboration with a wide range of functional disciplines such as Operations, Engineering, Business & Customers
  • Proven experience achieving results through use of coaching, influence, negotiation, persuasion
  • Strong people management skills including coaching and developing high performance team
  • Support Program / NPI in reviewing drawings and specs for compliance to customer and government regulations
  • Managing DP Level and Manifold product quality customer feedback, significant customer quality issues, and customer quality issue communications
  • Managing the Quality Steering Committee for DP Level and Manifold products
Qualifications for principal quality engineer
  • Ability to multi-task and work in aggressive timelines in an Agile/Scrum environment needed
  • Coding experience with scripting languages Perl, Python, Ruby
  • Multiple engineering or scientific disciplines (mechanical, materials, chemical, life sciences, ) experience is a plus
  • BS degree or equivalent in Business Management, Engineering, or other related field of study
  • MS or other technical graduate degree preferred
  • 5+ years’ experience in Strategic Customer Experience management within a Product or service environment

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