Senior Supplier Quality Engineer

Job Title: Senior Supplier Quality Engineer Location: San Diego, CA Work Arrangement: Onsite Experience: Senior Level Industry Focus: Medical Devices / MedTech / Life Sciences Manufacturing Job Description We are seeking a Senior Supplier Quality Engineer to support critical suppliers and ensure the quality and reliability of purchased components, materials, and services. The role will focus on suppliers supporting commodities such as injection molding, plastics, subassemblies, mechanical components, and electronic components . The engineer will work closely with suppliers and internal engineering, manufacturing, and quality teams to drive supplier qualification, audits, process validation, corrective actions, and continuous improvement. Key Responsibilities Ensure suppliers consistently deliver quality parts, materials, and services that meet established requirements. Qualify and monitor suppliers according to company quality standards and procedures. Conduct and manage supplier audits to assess manufacturing processes, quality systems, GMP compliance, and overall supplier performance. Monitor supplier performance throughout the manufacturing lifecycle and resolve supplier-related quality issues. Lead and manage Supplier CAPA / SCAR activities and ensure timely corrective and preventive actions. Support supplier process validations and acceptance activities. Evaluate and disposition Supplier Change Requests (SCRs) and assess their potential impact on product quality. Develop and prioritize supplier audit schedules based on supplier risk and performance. Evaluate supplier manufacturing and quality functions and provide recommendations for improvement. Support New Product Development (NPD) activities by providing supplier quality engineering expertise. Partner with Component Engineering, Manufacturing, Quality, and other cross-functional teams to prevent defects and ensure reliable product quality. Define Receiving Inspection requirements and support associated test method validation. Support quality agreement development and negotiations with suppliers. Drive supplier quality improvements through data analysis, corrective actions, process improvements, and continuous improvement initiatives. Maintain compliance with applicable GMP and quality-system requirements . Required Qualifications Bachelor's degree in Engineering or a related technical field preferred. Strong experience in Supplier Quality Engineering (SQE) . Experience conducting supplier audits and supplier qualification . Hands-on experience with Supplier CAPA / SCAR . Experience with process validation . Knowledge of GMP and quality systems . Experience working with injection molding, plastics, mechanical components, subassemblies, or electronic components . Strong supplier management, problem-solving, and communication skills. Ability to work effectively with suppliers and cross-functional engineering/manufacturing teams. Preferred Qualifications Medical Device / MedTech industry experience. Experience with ISO 13485 . Experience evaluating and managing Supplier Change Requests (SCRs) . Receiving Inspection experience. Experience supporting New Product Development (NPD) . Experience with supplier quality in regulated manufacturing environments. Nice to Have ISO 13485 Lead Auditor Certification. ASQ Certified Quality Engineer (CQE). Six Sigma or other Continuous Improvement certification. Experience leading cross-functional quality projects.

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