Supplier Quality Engineer - Medical devices

Purpose

The Supplier Quality Engineer will be responsible for end-to-end supplier quality activities, including APQP execution, process validation (IQ/OQ/PQ/TMV), PV testing, data analysis, and support for manufacturing line design (MLD) changes.

The role ensures supplier compliance with Quality Management System (QMS), medical device regulations, and global quality standards.

Key Responsibilities

APQP & Supplier Readiness

• Execute APQP activities including Specification Review, Product Quality Planning (PQP), PFMEA, Process Flow Diagrams, and Control Plans.
• Drive PSW closure and support First Article Inspection (FAI) reviews.
• Coach and support suppliers on APQP, validation readiness, and Good Documentation Practices (GDP).

Process Validation & PV Execution

• Lead and support execution of Process Validation activities (IQ/OQ/PQ/TMV) at supplier sites.
• Develop, review, and approve validation protocols and reports.
• Ensure timely closure of deviations, non-conformances, and CAPAs arising from validation activities.

Testing, Data Analysis & Capability

• Perform and review statistical analyses including MSA, GR&R, TMV, and process capability studies.
• Analyze PV data to assess process robustness and drive continuous improvement.
• Support process capability enhancements and risk mitigation initiatives.

MLD & Change Support

• Support Manufacturing Line Design (MLD) modifications and supplier process changes.
• Update PFMEA, Process Flow, and Control Plans to reflect changes and validation outcomes.

Documentation & Compliance

• Release and manage all APQP, validation, and quality deliverables in Windchill with accurate metadata.
• Maintain documentation in compliance with QMS, ISO 13485, and 21 CFR 820 requirements.
• Ensure traceability, audit readiness, and adherence to regulatory and internal quality standards.

Experience

• 58 years of experience in Supplier Quality, Manufacturing Quality, or Process Validation roles.
• Prior experience in medical devices or regulated industries strongly preferred.
• Strong hands-on knowledge of APQP, PPAP, PFMEA, IQ/OQ/PQ, TMV, MSA, and GR&R.
• Proven experience working directly with suppliers and managing validations at supplier sites.
• Solid understanding of ISO 13485, FDA 21 CFR 820, and quality system requirements.
• Strong technical documentation, analytical, and stakeholder communication skills.

rolly.martin@thompsonshr.com