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Supplier Quality Engineer

Katalyst Healthcares & Life Sciences

Northridge, CA

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JOB DETAILS
SKILLS
Agile Programming Methodologies, Auditing, Change Requests/Orders, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Desktop PC, Detail Oriented, Documentation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Information Technology/Systems Audit, Leadership, Maintain Compliance, Manufacturing, Medical Equipment, Problem Solving Skills, Process Validation, Product Lifecycle Management, Production Part Approval Process (PPAP), Purchasing/Procurement, Quality Assurance, Quality Engineering, Regulations, Requirements Validation/Verification, Risk, Root Cause Analysis, SAP, Systems Analysis, Team Lead/Manager, Team Player, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Management, Windchill PLM Software
LOCATION
Northridge, CA
POSTED
30+ days ago
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

About the Company

K

Katalyst Healthcares & Life Sciences

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