Supplier Quality Engineer

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

Job Summary

• Supplier Quality Engineer role requiring strong hands-on experience in supplier qualification, approval, and lifecycle management.
• The candidate should have proven capability in managing Approved Supplier Lists (ASL), conducting supplier audits, and handling PPAP submissions for medical device components.
• Requires solid understanding of process validation (IQ/OQ/PQ), risk-based decision-making aligned with ISO 14971, and expertise in root cause analysis.
• Familiarity with electronic QMS/PLM systems such as TrackWise, Agile, Windchill, and SAP is essential, along with the ability to collaborate across cross-functional teams and manage multiple suppliers in a regulated environment.

Roles & Responsibilities

• Maintain and update the Approved Supplier List (ASL), including supplier addition, re-approval, suspension, or disqualification
• Conduct supplier evaluations including quality system assessments, technical capability reviews, and regulatory compliance checks
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and Supplier Quality requirements
• Collaborate with Procurement and Operations to ensure only ASL-approved suppliers are used for sourcing and production
• Define PPAP scope and level based on component risk, regulatory impact, and supplier maturity
• Act as the PPAP focal point for suppliers, ensuring timely and complete submission of PPAP packages
• Ensure process validations (IQ/OQ/PQ) are completed when applicable for critical or special processes
• Evaluate Supplier Change Requests (SCRs) for quality, regulatory, and risk impact
• Participate in root cause analysis, CAPA activities, and continuous improvement initiatives as required
• Support readiness for internal, customer, and regulatory audits
• Collaborate with Manufacturing, Engineering, and Supplier Quality teams to resolve quality issues in a timely manner

Experience

• Strong hands-on experience in supplier qualification, approval, and lifecycle management
• Proven capability to create, manage, and maintain Approved Supplier Lists (ASL)
• Experience conducting supplier quality system audits (on-site / remote / desktop)
• Hands-on experience leading or reviewing PPAP submissions for medical device components
• Working knowledge of process validation requirements (IQ/OQ/PQ) for supplier processes
• Strong understanding of risk-based decision making aligned with ISO 14971 principles
• Strong skills in root cause analysis and problem-solving methodologies
• Familiarity with electronic QMS / PLM systems (e.g., TrackWise, Agile, Windchill, SAP)
• Ability to work effectively with Procurement, Engineering, Manufacturing, QA, and Regulatory Affairs
• Strong supplier communication skills (technical discussions, expectations, escalation)
• Ability to manage multiple suppliers and PPAPs simultaneously in a regulated environment
• Strong attention to detail and documentation accuracy
• Compliance-focused mindset
• Ability to work independently and escalates issues appropriately
• Effective communication and collaboration skills