Supplier Quality Engineer

Job Title: Supplier Quality Engineer Location: Pleasanton, CA

Experience: 5–8 years Duration: 6–12 Months

Job Description

We are seeking an experienced Supplier Quality Engineer with a strong background in the medical device industry. The ideal candidate will be responsible for managing supplier quality processes, ensuring compliance with regulatory standards, and driving continuous improvement across the supply chain.

Responsibilities

• Collaborate with US and overseas suppliers to ensure quality standards are met.

• Lead supplier evaluations, qualification, and onboarding activities.

• Plan and execute supplier audits in compliance with industry and regulatory requirements.

• Perform First Article Inspections (FAI) and component qualifications for supplier-provided parts.

• Support and review process validations, including IQ, OQ, and PQ.

• Manage supplier-related quality issues, including SCARs, root cause analysis (RCA), and CAPA.

• Maintain and update documentation through PLM systems, ensuring revision control and release compliance.

• Communicate effectively with internal stakeholders and suppliers to resolve issues and maintain high quality standards.

Requirements

• 5–8 years of supplier quality engineering experience in the medical device industry .

• Proven experience in supplier evaluation, audits, and onboarding.

• Hands-on knowledge of FAI, component qualification, and process validation (IQ, OQ, PQ).

• Strong background in managing SCARs, RCA, and CAPA.

• Experience with PLM systems for document control and release.

• Excellent verbal and written communication skills.