06 Aug
|
HealthMinds Consulting
|
Bengaluru
06 Aug
HealthMinds Consulting
Bengaluru
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 docume
📌 Senior Supplier Quality Engineer – PPAP (Bengaluru)
🏢 HealthMinds Consulting
📍 Bengaluru