Senior Supplier Quality Engineer, Medical Devices

HCL Technologies Limited; Minneapolis (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

HCL Technologies Limited is seeking a Supplier Quality Engineer in the medical device space to evaluate and onboard suppliers, assess product quality, and manage PPAP documentation. You will coordinate supplier audits, assist with process validation, and ensure robust supplier quality processes are in place.

The role requires advanced knowledge of regulatory standards, DFMEA/PFMEA/MSA, and PLM-based documentation.

Qualifications

• Bachelor’s degree in engineering, technical, or scientific discipline is required.
• Minimum 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
• Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
• Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).

Responsibilities

• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Review PPAP documentation and approve Control Plans, Process Flow Charts, DFMEA, PFMEA and related records.
• Facilitate supplier audits and Supplier Quality Agreements.
• Coordinate supplier evaluation for new sources or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ) and MSA/TMV.
• Route documentation in PLM systems and obtain approvals/releases.
• Collaborate with Global Supplier Quality teams on SDR/SOQ activities.

Skills

Analytical skills

Communication

Cross-functional collaboration

PLM systems

Education

Bachelor’s degree in engineering/technical/scientific discipline

Tools

Quality documentation tools

Job description

HCL Technologies Limited is seeking a Supplier Quality Engineer in the medical device space to evaluate and onboard suppliers, assess product quality, and manage PPAP documentation. You will coordinate supplier audits, assist with process validation, and ensure robust supplier quality processes are in place.

The role requires advanced knowledge of regulatory standards, DFMEA/PFMEA/MSA, and PLM-based documentation.