Senior Supplier Quality Engineer - Medical Devices

Katalyst-Healthcares-; Arden Hills (MN); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst-Healthcares in Arden Hills, MN seeks a Supplier Quality Engineer to ensure suppliers deliver high-quality materials meeting medical device standards and regulatory requirements. You will manage supplier qualification, audits, risk assessments, and cross-functional collaboration across global teams.

Responsibilities include PPAP reviews, DFMEA/PFMEA, ASL management, CAPA, and continuous improvement to enhance supplier quality and product reliability across the supply chain.

Qualifications

• Bachelor's degree in engineering or scientific field.
• Minimum 8 years in supplier quality within medical devices.
• Strong knowledge of medical device QMS and regulatory requirements.
• Hands-on supplier qualification, audits, and ASL management.

Responsibilities

• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Review PPAP documentation and related quality records (CPK/DFMEA/PFMEA).
• Perform supplier risk segmentation and mitigation planning.
• Coordinate supplier evaluations for new or changed components/processes.
• Support IQ/OQ/PQ and validation activities across teams.
• Collaborate with Global Supplier Quality and drive CAPA actions.

Skills

Supplier Quality

Risk Management

Audits

PPAP

CAPA

QMS Knowledge

Education

Bachelor's degree in engineering

Tools

PLM systems

ASL management

IQ/OQ/PQ processes

Job description

Katalyst-Healthcares in Arden Hills, MN seeks a Supplier Quality Engineer to ensure suppliers deliver high-quality materials meeting medical device standards and regulatory requirements. You will manage supplier qualification, audits, risk assessments, and cross-functional collaboration across global teams.

Responsibilities include PPAP reviews, DFMEA/PFMEA, ASL management, CAPA, and continuous improvement to enhance supplier quality and product reliability across the supply chain.