KH
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Manager or above
5 months ago
- Agile
- Windchill
- SAP
- Regulatory Compliance
- CAPA
5 months ago
- 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
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences