Description

Key Responsibilities

• Support supplier qualification, technical assessments, and supplier selection.
• Develop and manage APQP plans supporting NPI activities.
• Lead or support PFMEA, Control Plans, MSA, SPC, FAI, process validation, and PSW activities.
• Establish and maintain supplier quality requirements and documentation.
• Partner with R&D, Manufacturing, Engineering, and suppliers on DfX/DFM initiatives.
• Ensure Critical-to-Quality (CtQ) and Critical-to-Safety (CtS) characteristics are properly defined and controlled.
• Support supplier development, performance improvement, and quality monitoring.
• Manage supplier quality issues, investigations, containment, and corrective actions.
• Review and support SCARs, CAPA, and root cause analysis.
• Conduct supplier qualification, surveillance, and for-cause audits.
• Support Approved Supplier List (ASL) activities.
• Collaborate cross-functionally throughout NPI, design transfer, validation, and production launch.

Required Qualifications

• Bachelor's or Master's degree in Engineering or a related technical discipline.
• 5+ years of relevant professional experience in Supplier Quality Engineering, Process Engineering, Design Engineering, Continuous Improvement, or related areas.
• Experience in supplier quality management within a regulated manufacturing environment.
• Experience with NPI, APQP, supplier qualification, process validation, and design transfer.
• Experience with supplier audits and supplier development.
• Strong understanding of quality tools including PFMEA, Control Plans, MSA, SPC, FAI, CAPA, and root cause analysis.
• Experience working in an FDA-regulated and/or ISO 13485 environment.
• Knowledge of ISO 13485, FDA QSR/21 CFR 820, ISO 14971, and/or MDSAP.
• Strong analytical, problem-solving, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Medical device manufacturing or supplier quality experience.
• Lean Six Sigma certification.
• Experience with IQ/OQ/PQ, PPAP/PSW, test method validation, and supplier qualification plans.
• Experience managing complex supplier quality issues and driving measurable improvements.
• Experience working closely with R&D, Manufacturing, Engineering, and external suppliers during NPI.

Candidate Submittal Requirements

Candidates should be prepared to provide detailed responses covering:

1. Medical Device Supplier Quality Experience – Experience in FDA/ISO 13485 environments, supplier qualification, applicable regulations, and results achieved.
2. APQP, Qualification & Validation Experience – Level of involvement with PFMEA, Control Plans, MSA, SPC, validation, FAI, PPAP/PSW, and supplier qualification.
3. Significant Supplier Quality Issue – Investigation methodology, root cause, CAPA, and measurable outcome.
4. Supplier Audits & Development – Audit experience, standards used, findings, supplier improvements, and results.
5. NPI / Cross-Functional Project – Experience partnering with R&D, Manufacturing, and suppliers, including CtQ/CtS, DFM/DfX, validation, and launch activities

Key Skills

Education

Bachelor's or Master's degrees