Expertise in conducting supplier audits with a focus on compliance
Strong background in PPAP submissions for medical devices
Solid understanding of process validation (IQ/OQ/PQ)
Familiarity with electronic QMS systems like TrackWise and SAP
Effective cross-functional collaboration skills
Responsibilities
Maintain and update the Approved Supplier List (ASL) with necessary actions
Conduct supplier evaluations to assess quality systems and compliance
Ensure adherence to ISO 13485 and FDA regulations
Collaborate with teams to source only from ASL-approved suppliers
Define and manage the scope of PPAP submissions based on risk
Act as liaison for PPAP submissions, ensuring timely completion
Oversee process validations for critical supplier processes
Evaluate Supplier Change Requests for potential impacts
Participate in root cause analysis and corrective action efforts
Support audits by preparing documentation and ensuring readiness
Work with various teams to quickly resolve quality concerns
Benefits
Opportunities for professional growth and development
Collaborative work environment with cross-functional teams
Exposure to industry best practices in supplier quality management
Support for continuous improvement initiatives
Participation in compliance and regulatory audit preparations
Full 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
ct 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)
