Senior Supplier Quality Leader – Medical Devices

Nextern; Maple Grove (MN); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health Plan

Retirement Plan with Company Match

Paid Time Off

Birthday Holiday

Life Insurance

Family Leave

Short-Term / Long-Term Disability

Snacks & Wellness Resources

Job summary

Nextern is seeking a seasoned Supplier Quality Engineer in Minnesota to lead supplier onboarding, qualification, and monitoring across the material and component supply chain. You will partner with development, manufacturing, and quality teams to ensure supplier documentation, change management, and NC/CAPA processes are robust and compliant.

Ideal candidates bring 10+ years in medical device quality or 5+ years in supplier quality engineering, with ISO 13485 and 21 CFR 820 experience, and

Qualifications

• Bachelor's degree in life science or equivalent experience.
• 10+ years in medical device quality function, or 5+ years in supplier quality/engineering.
• Experience with 21 CFR 820 and ISO 13485 quality systems.
• ISO 13485 Lead Auditor certification (BSI or equivalent).
• Understanding of ISO 14971 risk management for supplier qualification.
• Strong technical leadership in quality and attention to detail.
• Excellent written and verbal communication across teams.
• Experience with quality tools: nonconformance, CAPAs, root cause analysis.
• Familiarity with Minitab; PLM software Windchill/Agile/Propel; MS Office.

Responsibilities

• Partner with development and supply chain to onboard and monitor suppliers.
• Assess material and supplier characteristics for categorization.
• Maintain supplier files to ensure traceability and control.
• Ensure supplier docs meet business and program requirements.
• Handle supplier change notifications and coordinate SMEs.
• Lead Supplier Corrective Action Requests (SCARs).
• Coordinate material testing for supplier qualification.
• Define monitoring plans for receiving inspection and supplier data.
• Analyze and present supplier performance metrics for reviews.
• Own supplier selection, qualification, and monitoring QMS processes.
• Lead audits and support external/internal audits as SME.
• Identify efficiency improvements in Quality System requirements.

Skills

Quality systems knowledge

Supplier quality leadership

Root cause analysis

Communication skills

CAPA management

Audit coordination

Statistical software (Minitab)

PLM software experience

Education

Bachelor's Degree in life science or equivalent

Tools

Windchill

Agile

Propel

Minitab

MS Office

Job description

Nextern is seeking a seasoned Supplier Quality Engineer in Minnesota to lead supplier onboarding, qualification, and monitoring across the material and component supply chain. You will partner with development, manufacturing, and quality teams to ensure supplier documentation, change management, and NC/CAPA processes are robust and compliant.

Ideal candidates bring 10+ years in medical device quality or 5+ years in supplier quality engineering, with ISO 13485 and 21 CFR 820 experience, and