Senior Supplier Quality Engineer - Med Device QA

Nextern; Maple Grove (MN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health plan (Medical, Dental & Vision)

Retirement plan with company match

Paid time off & Personal days

Birthday holiday

Life insurance & AD&D

Disability insurance

Wellness resources

Job summary

Nextern in Minnesota is seeking a Supplier Quality Engineer to partner with development, manufacturing, supply chain and quality teams to onboard and qualify new suppliers and monitor ongoing performance. You will act as the primary liaison to Nextern suppliers for quality communications, change notifications, audits and CAPA, while ensuring compliance with 21 CFR 820 and ISO 13485.

This role requires leadership, data analysis, and the ability to coordinate supplier visits and audits to drive

Qualifications

• BS in life science or equivalent education/experience.
• 10+ years in medical device quality 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).
• Strong communication and leadership across disciplines.

Responsibilities

• Partner with development, manufacturing, supply chain and quality teams to qualify suppliers.
• Assess supplier material and characteristics for categorization and monitoring.
• Maintain supplier files for traceability and supplier data linkage.
• Coordinate supplier change notifications and supplier corrective actions (SCARs).
• Lead supplier audits and support internal audits as SME for QMS processes.

Skills

Quality leadership

Regulatory knowledge

Data analysis

Quality tools (CAPA, RCA)

Communication

Education

BS in life sciences

Tools

Windchill

Agile

Propel

Minitab

MS Office

Job description

Nextern in Minnesota is seeking a Supplier Quality Engineer to partner with development, manufacturing, supply chain and quality teams to onboard and qualify new suppliers and monitor ongoing performance. You will act as the primary liaison to Nextern suppliers for quality communications, change notifications, audits and CAPA, while ensuring compliance with 21 CFR 820 and ISO 13485.

This role requires leadership, data analysis, and the ability to coordinate supplier visits and audits to drive