Sr. Quality Assurance Engineer

Nextern; Maple Grove (MN); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Health care plan

Retirement plan with company match

Paid time off and personal days

Birthday holiday

Life insurance

MN paid leave

Disability (short-term & long-term)

Taco Thursdays

Job summary

Nextern is seeking a Sr. Quality Assurance Engineer in Minnesota to drive quality across the product lifecycle, from development through commercial manufacturing. You will lead QA activities, author SOPs, and support audits, ensuring DHFs and records comply with ISO 13485 and 21 CFR 820.

You will collaborate with manufacturing, suppliers, and customers, applying root-cause analysis and CAPA processes to sustain continuous improvement and product quality.

Qualifications

• Bachelor's Degree in a STEM field required.
• 5+ years in Design Assurance or Quality Engineering in medical devices.
• Experience with 21 CFR 820 and ISO 13485.
• Experience leading QA activities in complex device programs.
• Familiarity with PLM software (Windchill/Agile/Propel).
• Strong communication and analytical skills.

Responsibilities

• Author and approve SOPs, work instructions, and forms; support audits and readiness.
• Track quality metrics; drive corrective and preventive actions.
• Oversee incoming inspection and disposition of nonconforming materials.
• Provide QA oversight for IQ/OQ/PQ activities and change control.
• Manage CAPAs from initiation through verification; perform root-cause analysis.
• Act as QA contact for production and review GMP documentation.
• Support audits as SME for QMS processes and DHFs.

Skills

Quality Assurance

Documentation & SOPs

Regulatory compliance

Risk management

Data analysis

Communication

MS Office

Education

Bachelor's Degree in STEM

Tools

Windchill

Agile

Propel

Minitab

Job description

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

The Sr;. Quality Assurance Engineer is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

RESPONSIBILITIES:

• Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.
• Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.
• Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
• 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.
• 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.
• 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 (or lack thereof) 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.

Required:

• Bachelor's Degree (BS) in a STEM related field
• 5+ years of experience in a Design Assurance or Quality Engineering role in the medical device industry
• Experience working in quality systems as defined in 21 CFR 820 and ISO 13485
• Development project team member on complex medical device development programs, including systems
• Understanding of ISO 14971 and application of risk management to product development and processes
• Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..)
• Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
• Demonstrated technical expertise and leadership in quality
• High attention to detail, organization, and accuracy
• Instinctual capability for creative thinking and proposing novel solutions
• Strong ability to communicate (written and verbally) within and across disciplines and organization structures
• Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook)

Preferred:

• Familiarity with statistical software, such as Minitab, preferred.

Salary Range: $100,000 to $125,000 based on skills and experience

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• MN Paid Leave
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.