Senior Quality Assurance Engineer - Medical Devices & PLM

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

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.