Senior QA Engineer, Medical Devices - Compliance Leader

Nextern; Maple Grove (MN); Sur place; USD 100 000 - 135 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement Plan with Company Match

Paid Time Off

Birthday Holiday

Wellness Resources

Life Insurance

Family Leave

Disability Insurance

Résumé du poste

Nextern is seeking a Quality Assurance Engineer in Minnesota to drive quality input across the product lifecycle, from development to manufacturing readiness and post-market activities. You will author SOPs, support audits, and ensure DHF compliance.

The role emphasizes CAPAs, nonconformances, root cause analysis, and collaboration with cross-functional teams to maintain compliance with 21 CFR 820, ISO 13485, and ISO 14971.

Qualifications

• Bachelor's degree in life sciences or equivalent experience.
• 5+ years in quality assurance within a medical device development setting.
• Experience with 21 CFR 820 and ISO 13485 quality systems.
• Experience as a development team member on complex medical device programs.
• Understanding of ISO 14971 risk management in product development.
• Proven leadership and strong communication across disciplines.
• Experience with PLM software (Windchill, Agile, Propel) and MS Office.

Responsabilités

• Author and approve SOPs, work instructions, and forms; support audits and inspection readiness.
• Compile and trend quality metrics; present insights and drive CAPA implementation.
• Oversee incoming inspection; disposition nonconforming materials; coordinate supplier actions.
• Provide QA oversight for IQ/OQ/PQ qualification activities; review protocols and change orders.
• Manage nonconformances and CAPAs from initiation through effectiveness, including root cause analysis.
• Act as QA point of contact for production; review batch records for GMP compliance.
• Support line clearances, first-article inspections, and process change reviews.
• Draft and approve product and engineering work orders; maintain DHF.
• Guide project teams in QA/Regulatory best practices; document changes and impacts.

Connaissances

Quality Assurance

Regulatory knowledge

Risk management

Documentation

Cross-functional collaboration

Communication skills

Formation

Bachelor's degree in life sciences

Outils

Windchill

Agile PLM

Propel

MS Office

Description du poste

Nextern is seeking a Quality Assurance Engineer in Minnesota to drive quality input across the product lifecycle, from development to manufacturing readiness and post-market activities. You will author SOPs, support audits, and ensure DHF compliance.

The role emphasizes CAPAs, nonconformances, root cause analysis, and collaboration with cross-functional teams to maintain compliance with 21 CFR 820, ISO 13485, and ISO 14971.