Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

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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 escalate issues appropriately
Effective communication and collaboration skills

Location

Northridge, CA