Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Location: San Diego, CA | Onsite

Job Summary

Seeking a Senior Supplier Quality Engineer to support critical suppliers and key quality initiatives across commodities including injection molding, plastics, subassemblies, and mechanical and electronic components. This role will focus on supplier qualification, audits, process validation, CAPA/SCAR management, quality agreements, supplier changes, and receiving inspection requirements within a quality-focused manufacturing environment.

Responsibilities

• Ensure suppliers consistently deliver quality parts, materials, and services.

• Qualify and evaluate suppliers according to established quality standards.

• Conduct supplier audits and develop audit schedules to ensure compliance with GMP and quality requirements.

• Monitor supplier quality throughout the manufacturing cycle and resolve supplier-related issues through CAPA/SCAR processes.

• Support supplier process validations and acceptance activities.

• Evaluate supplier operations and provide feedback on performance and quality-system effectiveness.

• Evaluate and disposition Supplier Change Requests (SCRs).

• Support negotiation and implementation of supplier quality agreements.

• Define receiving inspection requirements and associated test method validation, as needed.

• Provide supplier quality support for New Product Development (NPD), working with cross-functional teams to prevent defects and ensure reliable components and materials.

• Support other supplier quality activities related to critical suppliers and key projects.

Required Qualifications

• Experience in Supplier Quality Engineering (SQE).

• Experience with supplier audits and supplier qualification.

• Experience managing Supplier CAPA/SCAR activities.

• Experience with process validation and quality systems.

• Knowledge of GMP and quality standards.

• Experience with injection molding, plastics, mechanical components, or related supplier commodities.

• Bachelor's degree in Engineering or a related field preferred.

• Ability to work onsite in San Diego, CA.

Preferred Qualifications

• Medical device, MedTech, life sciences, or healthcare manufacturing experience.

• Experience with ISO 13485.

• Experience with Supplier Change Requests (SCR).

• Experience with receiving inspection requirements.

• Experience supporting NPD and pre-market supplier quality activities.

Nice to Have

• ISO 13485 Lead Auditor Certification.

• ASQ Certified Quality Engineer (CQE).

• Six Sigma or other continuous improvement certification.

• Experience leading quality or supplier-related projects.

Benefits

Benefits information will be provided during the hiring process.

Equal Opportunity Employer

We are committed to providing equal employment opportunities to all qualified applicants and maintaining an inclusive, professional, and nondiscriminatory work environment.

Application

Qualified candidates with strong supplier quality experience, particularly in medical devices, injection molding, plastics, or mechanical components, are encouraged to apply.