Supplier Quality Engineer

HCLTech; Minneapolis (MN); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Analytical skills

Communication

Cross-functional collaboration

PLM systems

Formation

Bachelor’s degree in engineering/technical/scientific discipline

Outils

Quality documentation tools

Description du poste

We are looking for a Supplier Quality Engineer at HCLTech the role entails

• Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
• Perform product and feature-level quality impact assessments and maintain necessary documentation.
• Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
• Facilitate Supplier Quality Agreements and conduct supplier audits.
• Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
• Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
• Route documentation in PLM systems and follow up for approvals and release.
• Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.

Qualifications & Experience:

• Bachelor’s degree in engineering, Technical, or Scientific discipline.
• 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).

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.
• Ability to work collaboratively with cross-functional and global teams.
• Proficiency in PLM systems and quality documentation tools.