Senior Supplier Quality Engineer – PPAP

Position Summary The Senior Supplier Quality Engineer will support the client's Supplier Quality Engineering organization by managing supplier qualification and Production Part Approval Process (PPAP) activities for medical device components and assemblies. This role will act as an extension of the client's quality team, collaborating with suppliers and internal cross-functional teams to ensure supplier processes, documentation, and products meet quality, regulatory, and production readiness requirements.

Key Responsibilities

- Support end-to-end PPAP activities for medical device suppliers, from initiation through final approval.
- Support in evaluating supplier and component requirements to determine the appropriate PPAP submission level and documentation needs.
- Serve as the primary liaison between the client and suppliers during PPAP execution, ensuring timely communication, issue resolution, and completion of deliverables.
- Review, assess, and approve supplier PPAP documentation, including:
- Part Submission Warrants (PSW)
- Process Flow Diagrams
- Process Failure Mode and Effects Analysis (PFMEA)
- Control Plans
- Dimensional Inspection Reports
- Material Certifications
- Measurement System Analysis (MSA) / Gauge R&R; Studies
- Process Capability Studies (Cp, Cpk, Pp, Ppk)
- First Article Inspection (FAI) Reports
- Validation documentation (IQ/OQ/PQ)
- Review supplier manufacturing processes to ensure adequate controls are established for consistent production of medical device components.
- Support supplier process qualification and production readiness activities.
- Review Device History Records (DHR), manufacturing records, and quality documentation for completeness and compliance.
- Identify PPAP gaps, risks, and non-conformities and work with suppliers to develop appropriate corrective actions.




- Manage PPAP revisions due to engineering changes, supplier changes, process modifications, or quality improvements.
- Maintain supplier PPAP records and documentation within MasterControl or equivalent electronic Quality Management System (eQMS).
- Provide supplier and component information to Procurement to support supplier onboarding and Purchase Order (PO) creation.
- Support supplier audits, quality reviews, and continuous improvement activities.
- Act as a Subject Matter Expert (SME) for supplier PPAP processes, supplier qualification, and quality documentation requirements.

Required Qualifications

- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field.
- 5–8+ years of experience in Supplier Quality Engineering, Quality Engineering, or Manufacturing Quality within a medical device or regulated industry.
- Strong experience managing supplier PPAP, supplier qualification, and production approval activities.
- Hands-on experience with medical device quality systems and documentation requirements.

Experience with:
- Measurement System Analysis (MSA)
- Process Capability Studies
- First Article Inspection (FAI)
- IQ/OQ/PQ Validation
- Device History Record (DHR) Review
- Supplier Corrective Actions (SCAR/CAPA)
- Experience working with MasterControl or similar electronic Quality Management Systems.
- Knowledge of medical device regulations and quality standards, including ISO 13485 and FDA 21 CFR Part 820.
- Solid analytical, problem-solving, communication, and supplier management skills.

Preferred Qualifications

- Experience supporting Class II/Class III medical device manufacturing.
- Knowledge of risk management principles (ISO 14971).
- Experience with supplier audits and manufacturing process validations.
- ASQ Certified Quality Engineer (CQE), Certified Supplier Quality Professional (CSQP), or equivalent certification preferred.

📌 Senior Supplier Quality Engineer – PPAP (India)
🏢 HealthMinds Consulting
📍 India