Senior Supplier Quality Engineer - Medical Devices

Katalyst CRO; Salt Lake City (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in Utah seeks an experienced Supplier Quality Engineer to lead supplier quality initiatives in the Medical Device sector. The role focuses on ensuring high-quality materials and components meet regulatory and internal standards, with expertise in PPAP, risk assessment, and quality systems.

The candidate will manage supplier onboarding, supplier audits, and CAPA activities, collaborating with cross-functional teams to maintain compliance and drive continuous improvement.

Qualifications

• Bachelor's degree in Engineering or related technical/scientific discipline.
• 8+ years of Supplier Quality Engineering experience in Medical Device.
• Strong understanding of FDA regulations, ISO 13485, and medical device QMS.
• Hands-on experience with supplier qualification, supplier development, and supplier quality management.
• Experience reviewing and approving PPAP documentation.

Responsibilities

• Manage supplier quality activities to ensure compliance with quality standards and regulatory requirements.
• Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
• Perform supplier assessments and quality evaluations for new products, components, and process changes.
• Review and approve PPAP documentation including DFMEA/PFMEA and Control Plans.
• Plan, coordinate, and perform supplier audits to ensure ongoing compliance.
• Collaborate with Global Supplier Quality teams to implement SDR and SOQ initiatives.
• Route quality documentation through PLM systems and ensure timely approvals and document releases.
• Investigate supplier quality issues, identify root causes, implement CAPA, and drive continuous improvement initiatives.

Skills

Supplier quality management

Process validation

Risk assessment

PPAP

Quality systems

Education

Bachelor's degree in Engineering or related

Tools

PLM systems

Job description

Katalyst CRO in Utah seeks an experienced Supplier Quality Engineer to lead supplier quality initiatives in the Medical Device sector. The role focuses on ensuring high-quality materials and components meet regulatory and internal standards, with expertise in PPAP, risk assessment, and quality systems.

The candidate will manage supplier onboarding, supplier audits, and CAPA activities, collaborating with cross-functional teams to maintain compliance and drive continuous improvement.