Principal Quality Assurance Engineer

Nextern•Maple Grove, MN

About The Position

The Principal Quality Assurance Engineer is responsible for manufacturing and device quality for commercial devices and manufacturing transfers. The role owns sustaining quality activities for investigational and commercial device manufacturing, including changes, audits, nonconformances, corrective and preventive actions (CAPAs), and complaint investigations, ensuring activities are completed on time. The position supports US manufacturing primarily and may support global manufacturing sites up to 10% of the time. As a Phase 4–5 project core team member, the engineer is accountable for product development deliverables and works across engineering functions to maintain compliance with the Quality System and applicable regulations and standards. The role also supports continuous improvement and, as needed, professional interaction with Nextern customers.

Requirements

Bachelor’s degree in an engineering discipline or an equivalent combination of education and experience.
At least 10 years of experience in medical device manufacturing.
Success 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.
Creative thinking and ability to propose novel solutions.
Strong written and verbal communication skills across disciplines and organizational structures.
Demonstrated use of quality tools and methodologies, such as nonconformance management, CAPAs, and root cause analysis.
Familiarity with common statistical software, such as Minitab.
Experience with Product Lifecycle Management (PLM) 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

Support US manufacturing primarily, with possible support for global manufacturing sites up to 10% of the time.
Serve as a Phase 4–5 project core team member accountable for product development deliverables.
Develop process risk assessments (PFMEAs), Master Validation Plans and Reports, failure and scrap code identification and maintenance aligned with process risks, 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, including verification and validation, as necessary.
Create and maintain up-to-date product Device Master Records (DMRs).
Compile, analyze, and present product-specific quality metrics for review forums.
Own manufacturing and Device History Record (DHR) review as part of complaint investigations.
Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Proactively identify redundancy and opportunities to improve Quality System requirements.
Own, review, and approve changes, ensuring impacts and resulting actions or decisions not to act are documented and executed appropriately.
Identify, own, and execute nonconformance investigations and implement corrective and preventive actions as necessary.
Support audits as a subject matter expert for Quality Management System processes and product-line manufacturing.
Lead Product Lifecycle Management (PLM) architecture and changes as needed.