Global Sr. Quality Assurance Engineer
About The Position
The Global Sr. Quality Assurance Engineer is responsible for manufacturing and device quality for commercial devices produced at Nextern’s global manufacturing sites. The role owns sustaining quality activities for investigational and commercial device manufacturing, including changes, audits, nonconformances, CAPAs, and complaint investigations, ensuring timely completion. The position works on-site at a U.S. facility, primarily supporting the Vietnam manufacturing site, with support for the Costa Rica site up to 20%. The role also supports compliance with the Quality System and relevant regulations and standards, continuous improvement, and professional interaction with Nextern customers as needed.
Requirements
- Bachelor’s degree (BS) in an engineering discipline.
- At least 5 years of experience in a medical device manufacturing quality role.
- Experience supporting global manufacturing sites.
- Success working in quality systems defined by 21 CFR 820 and ISO 13485.
- Fluency in electromechanical terminology and component naming conventions and functions.
- Basic understanding of electrical engineering principles and electrical diagnostic techniques.
- Expert-level knowledge and application of GMP and GDP.
- Understanding of ISO 14971 and application of risk management principles.
- Demonstrated technical expertise and leadership in quality.
- High attention to detail, organization, and accuracy.
- Capability for creative thinking and proposing novel solutions.
- Strong written and verbal communication 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 PLM software, such as Windchill, Agile, or Propel.
- Intermediate to advanced proficiency with Microsoft Office Suite (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
- Work on-site at a U.S. facility, primarily supporting the Vietnam manufacturing site, and provide Costa Rica site support up to 20%.
- Receive, open, investigate, and trend complaints.
- Identify, own, and execute nonconformance investigations and CAPAs.
- Compile, summarize, and present manufacturing and performance data internally and to customers.
- Partner with sustaining engineers to implement changes, drive improvements, and facilitate audits.
- Draft, collaborate on, and approve project deliverables and engineering work orders.
- Review, collaborate on, and approve changes to parts and documentation.
- Facilitate shipments between the manufacturing site and customer.
- Coordinate and execute process output testing (verification/validation) as necessary.
- Create and maintain up-to-date product Device Master Records (DMRs).
- Own manufacturing/DHR review as part of root cause investigations.
- Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Proactively identify redundancy and opportunities for improvement in Quality System requirements.
- Own, review, and approve changes, ensuring impacts and resulting actions or lack of action are properly documented and executed.
- Support audits as a Subject Matter Expert (SME) for QMS processes and product line manufacturing.
- Lead Product Lifecycle Management (PLM) architecture and changes as needed.
Benefits
- Health care plan (medical, dental, and vision).
- Retirement plan with company match.
- Paid time off and personal days.
- Birthday holiday.
- Lifetime membership subsidy and wellness resources.
- Life insurance (basic, voluntary, and AD&D).
- Family leave (maternity and paternity).
- Short-term and long-term disability.
- Taco Thursdays.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
