Procurement Engineering​/Supplier Transition

We are seeking a highly driven Procurement / Supplier Quality Engineer to lead supplier qualification, validation, and transition activities. This role is responsible for executing end-to-end supplier readiness through detailed engineering reviews, change management, hands-on validation, and documentation compliance.

The ideal candidate will act as a key interface between suppliers and cross-functional teams, ensuring timely project execution, quality compliance, and successful closure of all qualification activities.

• Execute and close supplier qualification activities through detailed engineering and supplier reviews
• Perform engineering drawing reviews (GD&T) to ensure manufacturability and compliance
• Drive Engineering Change Orders (ECOs) and change management activities
• Develop and execute validation protocols (IQ/OQ/PQ) ensuring compliance with cGMP and FDA regulations
• Plan and manage First Article Inspection (FAI) activities at supplier or plant locations
• Perform fit, form, and function testing and validation
• Complete and maintain PPAP, APQP, CQP, CQR, and related quality documentation
• Manage Supplier Corrective and Preventive Actions (CAPA) to closure
• Track and resolve supplier issues, ensuring timely project closure and documentation compliance
• Collaborate with Engineering, Quality, Procurement, Operations, and SQE teams
• Act as a single point of contact for suppliers, ensuring alignment on quality, cost, and schedule
• Escalate risks proactively and drive mitigation actions

• Bachelor s or Master s degree in Mechanical, Electrical, Manufacturing, Industrial Engineering, or related field
• Strong experience in supplier qualification, supplier development, or procurement engineering
• Hands-on experience with IQ/OQ/PQ validation and protocol execution
• Working knowledge of cGMP, FDA regulations, and quality compliance standards
• Experience with First Article Inspection (FAI) and supplier validation processes
• Strong understanding of engineering drawings, GD&T, and tolerances
• Experience with PPAP, APQP, and quality documentation processes
• Proficiency in CAPA management and issue resolution
• Ability to manage cross-functional collaboration and supplier communication
• Strong ownership mindset with the ability to drive tasks end-to-end to closure

• Experience with Solid Works or other CAD tools
• Knowledge of Lean Manufacturing / Six Sigma methodologies
• Experience in regulated industries (Medical Device, Pharma, Biotech)
• Exposure to supplier audits, ASTM standards, and process audits

Supplier Qualification | NPI | ECO | GD&T | Validation (IQ/OQ/PQ) | FAI | PPAP/APQP | CAPA | cGMP | FDA | Supplier Management | Cross-functional Coordination