Quality Assurance Engineer

Quality Assurance Engineer

This role is responsible for providing operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers support development activities as they prepare for commercial manufacturing, ensuring a smooth transition and continuously accurate and compliant Design History File. All engineering functions must comply with the Quality System and relevant regulations and standards, focusing on continuous improvement and professional interaction with external customers when needed.

Responsibilities

• Document Control & Audit Readiness: Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.
• Data & Continuous Improvement: Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.
• Incoming Inspection & Supplier Quality: Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
• Equipment & Process Oversight: Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation.
• NC & CAPA Leadership: Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone). Trend data and report findings at management review.
• Operations Quality Support: Act as the quality point of contact for production. Review batch records and travelers for GMP compliance. Support line clearances, first-article inspections, and process change reviews. Draft, collaborate, and approve product and engineering work orders.
• Create and maintain up-to-date product Design History Files (DHF). Advise project teams and lead by example in best practices for Quality and Regulatory Compliance. Own, review, and approve changes ensuring impacts and resulting action/implementation are properly documented and executed.
• Receive, investigate, and document product complaints, interacting with customers as applicable. Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs. Drive Product Lifecycle Management (PLM) architecture and changes, as needed.

Essential Skills

• 3 to 5 years' experience in Medical Device work history
• Experience in Design Assurance/Control and Quality Engineering
• Familiarity with quality systems as defined in 21 CFR 820 and ISO standards
• Development project team member on complex medical device development programs
• Understanding of ISO standards and application of risk management to product development and processes
• Demonstrated technical expertise and leadership in quality
• High attention to detail, organization, and accuracy
• Strong communication skills within and across disciplines and organization structures
• Demonstrated use of quality tools and methodologies (e.g., nonconformance, CAPAs, root cause analysis)

Additional Skills & Qualifications

• Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience
• 5+ years of experience in medical device development, or 3+ years in a Design Assurance or Quality Engineering role
• Familiarity with statistical software, such as Minitab, preferred
• Experience with Product Lifecycle Management (PLM) software (e.g., Windchill, Agile, Propel)
• Intermediate to advanced proficiency with MS Office Suite (Word, Excel, PowerPoint, Project, Outlook)

Work Environment

This position is located in a new facility in the Maple Grove Arden Lakes area, offering a dynamic work environment with a strong quality leadership team. There are various projects in the pipeline, providing an exciting and challenging atmosphere for engineers. The work environment encourages professional growth and development.

Job Type & Location

This is a Permanent position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $100000.00 - $125000.00/yr.

Nextern offers excellent benefits to fuel you in building a fulfilling life & career: - Employer subsidized health insurance for employees - Employer paid dental insurance - Employer HSA contribution - 401k plan with a company match - 9 paid holidays (including your birthday!) + PTO and Personal days - Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Workplace Type

This is a fully onsite position in Maple Grove, MN.

Application Deadline

This position is anticipated to close on May 22, 2026.