Sr. Supplier Quality Engineer - Injection Molding

Sr. Supplier Quality Engineer - Injection Molding (BH-399426)

Location San Diego, United States Sector Science & Research Salary $ to $ per annum

Yoh is seeking a Senior Supplier Quality Engineer for our client in San Diego. In this role, you will serve as a primary quality lead on cross-functional teams supporting new materials, supplier qualifications, and supplier-related changes. The Senior Supplier Quality Engineer will be responsible for developing and maintaining material specifications, managing supplier quality and performance, conducting supplier audits, leading investigations and corrective actions, and ensuring compliance with internal and external quality requirements, standards, and regulations.
The ideal candidate will bring extensive Quality Assurance and Supplier Management experience and must have experience with injection molding and plastics.
Industry: Medical Device Manufacturing
Location: Onsite
Compensation:$116, DOE
Type: Direct Hire

• Serve as the primary Quality lead on cross-functional teams supporting new materials, supplier qualifications, supplier changes, and supplier management activities.
• Develop and execute qualification programs for new materials and suppliers using a risk-based approach.
• Evaluate and monitor supplier risk levels to ensure suppliers and materials meet company quality requirements.
• Develop and execute the annual supplier audit program using a risk-based approach and provide guidance to ensure successful completion.
• Independently conduct internal and external supplier audits, approve audit reports, and ensure associated nonconformances and corrective actions are appropriately addressed.
• Lead investigations of low-, medium-, and high-risk material and supplier-related issues, determine root cause, and develop appropriate corrective and preventive action plans.
• Manage Supplier Corrective Action Requests (SCARs), including communication of nonconformances, investigation, root cause analysis, corrective action, and effectiveness assessment.
• Review, approve, and monitor supplier qualification and performance scorecards and ensure follow-up actions are completed within established timelines.
• Partner with suppliers to review and approve required quality documentation, including supplier questionnaires and improvement plans.
• Develop, monitor, and trend Supplier Quality System metrics to identify opportunities for continuous improvement.
• Create, review, and approve Supplier Quality procedures and documentation to ensure compliance with company requirements and applicable regulations.
• Review and assess supplier Quality Agreements to support timely supplier qualification.
• Independently author, review, and approve raw material specifications to support supplier and material qualification.
• Ensure appropriate material specifications are developed, maintained, reviewed, and approved.
• Lead critical supplier quality issues and stakeholder meetings, document meeting outcomes, and ensure timely completion of action items.
• Assess supplier change notifications and provide technical recommendations regarding potential impacts to product quality and the Quality Management System.
• Serve as a Subject Matter Expert (SME) for supplier-related change control processes and monitor implementation of approved changes.
• Provide Quality Assurance representation on projects involving new materials, material changes, and supplier management.
• Develop and support Quality System and procedural training programs for employees.
• Train and mentor team members within and outside of the Supplier Quality organization.
• Host third-party audits conducted by regulatory agencies, notified bodies, and business partners, including FDA inspections.
• Apply appropriate statistical methods and data analysis techniques to investigations, corrective actions, supplier performance, and continuous improvement activities.

Education, Licensure and/or Experience

• Bachelor's degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or a related scientific or engineering discipline required.
• Minimum of eight (8) years of relevant Quality Assurance experience.
• Minimum of five (5) years of Supplier Management experience.
• Experience with injection molding and plastics is required, including direct technical, maintenance, and/or quality experience.
• Demonstrated knowledge and experience with Good Manufacturing Practices (GMP) processes and procedures.
• Previous experience conducting and supporting supplier and Quality System audits.
• Experience with supplier qualification, supplier performance management, SCARs, root cause investigations, CAPA, and change control.
• Prior experience working with an electronic document management system required.
• Technical writing, trend analysis, and project leadership experience preferred.
• Experience implementing process improvements and analyzing quality trends is preferred.
• SAP experience is a plus.
• Strong technical writing skills with demonstrated ability to independently develop SOPs, forms, technical assessments,…