Supplier Quality Management

• Lead supplier selection, qualification, onboarding, and performance management activities.
• Conduct supplier audits and assessments to evaluate manufacturing capabilities, process controls, and quality management systems.
• Develop supplier improvement plans and monitor progress against established metrics.
• Establish and maintain supplier scorecards for quality, delivery, responsiveness, and cost performance.
• Support supplier risk assessments and mitigation activities.

PPAP & Process Validation

• Lead and review Production Part Approval Process (PPAP) submissions for new and existing suppliers.
• Review and approve key PPAP documentation including:
• Process Flow Diagrams
• PFMEA (Process Failure Mode and Effects Analysis)
• Control Plans
• Measurement System Analysis (MSA)
• Capability Studies (Cp/Cpk)
• First Article Inspection Reports (FAIR)
• Dimensional Results
• Material Certifications
• Ensure process validations and manufacturing controls are implemented and maintained by suppliers.
• Collaborate with suppliers to resolve PPAP deficiencies and qualification issues.

Quality Assurance & Compliance

• Ensure supplier compliance with ISO 13485 requirements and applicable regulatory standards.
• Support supplier quality activities associated with medical device manufacturing and applicable regulatory requirements.
• Participate in internal and external audits as subject matter expert for supplier quality processes.
• Ensure supplier documentation, records, and quality systems meet company and regulatory expectations.
• Support change control activities including supplier process changes, material changes, and manufacturing transfers.

Corrective and Preventive Actions

• Lead root cause investigations using methodologies such as:
• 8D
• 5 Why
• Fishbone Analysis
• Fault Tree Analysis
• Drive supplier corrective and preventive action (CAPA) effectiveness.
• Verify implementation and sustainability of corrective actions.
• Escalate recurring supplier quality issues as appropriate.

Continuous Improvement

• Identify and implement supplier process improvements that enhance quality, reliability, capacity, and cost.
• Utilize Lean Manufacturing and Six Sigma tools to drive continuous improvement initiatives.
• Collaborate with Engineering, Operations, Procurement, and Quality teams to reduce risk and improve supplier performance.
• Support cost reduction and value engineering initiatives.

Education

• Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or related technical discipline.

Experience

• 5+ years of experience in Supplier Quality Engineering, Supplier Development, Manufacturing Engineering, Quality Engineering, or related field.
• Experience working within regulated manufacturing environments.
• Demonstrated experience with PPAP, APQP, PFMEA, Control Plans, and MSA.
• Experience conducting supplier audits and managing supplier corrective actions.
• Experience working with ISO 13485 quality management systems.
• Strong understanding of manufacturing processes including machining, molding, assembly, electronics, metals, plastics, or medical device manufacturing.

Technical Skills

• Working knowledge of:
• PPAP
• APQP
• PFMEA
• SPC
• MSA
• Control Plans
• GD&T
• Root Cause Analysis
• CAPA Systems
• Proficiency with quality tools and statistical analysis methods.
• Ability to interpret engineering drawings, specifications, and technical standards.
• Experience using ERP, PLM, and quality management systems.

Preferred Qualifications

• ASQ Certified Supplier Quality Engineer (CSQE), Certified Quality Engineer (CQE), or equivalent certification.
• Lead Auditor certification for ISO 13485 or ISO 9001.
• Six Sigma Green Belt or Black Belt certification.
• Experience supporting FDA-regulated medical device manufacturing environments.