Senior Supplier Quality Engineer – Medical Devices

Katalyst CRO; Los Angeles (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a hands-on Supplier Quality Engineer to own supplier qualification, approval, and lifecycle management for medical device components. You will manage ASLs, conduct supplier audits, and drive PPAP submissions in a regulated setting.

The role requires IQ/OQ/PQ process validation understanding, risk-based decision making per ISO 14971, and collaboration with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs to ensure compliant sourcing across multiple

Qualifications

• Hands-on supplier qualification and lifecycle management.
• Experience managing Approved Supplier Lists (ASL).
• Experience conducting supplier quality system audits (on-site/remote).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Experience leading PPAP submissions for medical device components.
• Understanding of IQ/OQ/PQ process validation.
• Strong, risk-based decision making per ISO 14971.
• Ability to collaborate with Procurement, Engineering and QA.

Responsibilities

• Maintain and update the Approved Supplier List (ASL) including supplier changes.
• Conduct supplier evaluations and regulatory compliance checks.
• Ensure ASL-approved sourcing for procurement and production.
• Define PPAP scope and act as PPAP focal for suppliers.
• Oversee IQ/OQ/PQ validations for critical processes as needed.
• Review SCRs for quality, regulatory and risk impact.
• Lead root cause analysis and CAPA activities.
• Support audits readiness for internal, customer, and regulatory reviews.
• Collaborate with cross-functional teams to resolve issues promptly.

Skills

Supplier qualification

ASL management

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Process validation

Risk-based decisions

Tools

TrackWise

SAP

Windchill

Agile

Job description

Katalyst CRO is seeking a hands-on Supplier Quality Engineer to own supplier qualification, approval, and lifecycle management for medical device components. You will manage ASLs, conduct supplier audits, and drive PPAP submissions in a regulated setting.

The role requires IQ/OQ/PQ process validation understanding, risk-based decision making per ISO 14971, and collaboration with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs to ensure compliant sourcing across multiple