Pr. Quality Assurance Engineer
About The Position
The Pr. Quality Assurance Engineer is responsible for manufacturing and device quality for commercial devices and manufacturing transfers. The role owns sustaining activities for investigational and commercial device manufacturing, including changes, audits, nonconformances, CAPAs, and complaint investigations, ensuring timely completion. The engineer is also responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and professional interaction with Nextern customers as needed. The role primarily supports US manufacturing and may support global manufacturing sites up to 10%. As a Phase 4–5 project core team member, the engineer is accountable for product development deliverables and supports product lifecycle management architecture and changes as needed.
Requirements
- Bachelor's degree in an engineering discipline, or an equivalent combination of education and experience.
- 10+ years of experience in medical device manufacturing.
- Successful experience working in quality systems defined by 21 CFR 820 and ISO 13485.
- Expert-level knowledge and application of GMP and GDP.
- Intimate understanding of ISO 14971 and application of risk management principles.
- Demonstrated technical expertise and leadership in quality.
- High attention to detail, organization, and accuracy.
- Ability to think creatively and propose novel solutions.
- Strong written and verbal communication skills within and across disciplines and organizational structures.
- Demonstrated use of quality tools and methodologies, such as nonconformance, CAPAs, and root cause analysis.
- Familiarity with common statistical software, such as Minitab.
- Experience with Product Lifecycle Management software, such as Windchill, Agile, or Propel.
- Intermediate to advanced proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, Project, and Outlook.
Nice To Haves
- Secondary certification in Quality, such as CQE or CQA.
- Knowledge of lean principles, such as Six Sigma.
Responsibilities
- Primarily support US manufacturing, with potential support for global manufacturing sites up to 10%.
- Serve as a Phase 4–5 project core team member accountable for product development deliverables, including process risk assessments (PFMEA), Master Validation Plans and Reports, failure/scrap code identification and maintenance, and manufacturing, process monitoring, and product acceptance plans.
- Draft, collaborate on, and approve project deliverables and engineering work orders.
- Coordinate and execute process output testing (verification/validation), as necessary.
- Create and maintain up-to-date product Device Master Records (DMR).
- Compile, analyze, and present product-specific Quality metrics for review forums.
- Own manufacturing/DHR review as part of complaint investigations.
- Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Identify redundancies and opportunities to improve Quality System requirements.
- Own, review, and approve changes, ensuring impacts and resulting actions or implementation decisions are documented and executed.
- Identify, own, and execute nonconformance investigations and corrective and preventive actions, as necessary.
- Support audits as a Subject Matter Expert for QMS processes and product-line manufacturing.
- Lead Product Lifecycle Management (PLM) architecture and changes, as needed.
Benefits
- Health care plan including medical, dental, and vision coverage.
- Retirement plan with company match.
- Paid time off, personal days, and a birthday holiday.
- Lifetime membership subsidy and wellness resources.
- Life insurance (basic, voluntary, and AD&D).
- Family leave, including maternity and paternity leave.
- Short-term and long-term disability coverage.
- Taco Thursdays.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
