Supplier Quality Engineer

Kelly Science, Engineering, Technology & Telecom; San Diego (CA); On-site; USD 125,000 - 180,000; Full time

Job summary

Kelly Science & Clinical is seeking a Senior Supplier Quality Engineer to serve as the primary Quality lead on cross-functional teams focused on new materials, supplier qualification, supplier changes, and Quality Management System compliance for a healthcare/biopharmaceutical company in San Diego.

The role involves leading supplier audits, managing nonconformances, reviewing quality docs, and supporting FDA/third-party audits, with a focus on continuous improvement and mentoring quality

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or related field.
• 8+ years of Quality Assurance experience, including 5+ years in supplier management.
• Experience with injection molding and plastics is required.
• Strong GMP knowledge in a regulated manufacturing environment.
• Excellent technical writing, communication, presentation, analytical and project management skills.
• Experience with electronic document management systems.
• SAP experience preferred.

Responsibilities

• Lead risk-based supplier audits, qualification programs, and supplier performance monitoring.
• Manage supplier nonconformances (SCARs) and root-cause investigations.
• Review and approve supplier quality documentation, raw-material specifications, and technical assessments.
• Lead internal/external audits and support FDA, notified body, and other third-party audits.
• Develop supplier quality metrics and identify continuous improvement opportunities.
• Author and approve SOPs, risk assessments, specifications, and other quality documentation.
• Serve as a Subject Matter Expert for supplier quality and material-related issues.
• Collaborate with cross-functional teams and suppliers while mentoring and supporting quality initiatives.

Skills

GMP knowledge

Technical writing

Communication

Presentation

Analytical

Project management

Electronic document management systems

Education

Bachelor’s degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or related field

Tools

SAP

Job description

Kelly Science & Clinical is seeking a Senior Supplier Quality Engineer to serve as a primary Quality lead on cross-functional teams focused on new materials, supplier qualification, supplier changes, and Quality Management System compliance for a healthcare/biopharmaceutical company in San Diego.

Key responsibilities:

• Lead risk-based supplier audits, qualification programs, and supplier performance monitoring.
• Manage supplier nonconformances (SCARs), root-cause investigations, corrective actions, and change notifications.
• Review and approve supplier quality documentation, quality agreements, raw-material specifications, and technical assessments.
• Lead internal/external audits and support FDA, notified body, and other third-party audits.
• Develop supplier quality metrics and identify continuous improvement opportunities.
• Author and approve SOPs, risk assessments, specifications, and other quality documentation.
• Serve as a Subject Matter Expert for supplier quality and material-related issues.
• Collaborate with cross-functional teams and suppliers while mentoring and supporting quality initiatives.

Qualifications:

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or related field.
• 8+ years of Quality Assurance experience, including 5+ years in Supplier Management.
• Experience with injection molding and plastics (direct expertise, maintenance, or quality) is absolutely required.
• Strong GMP knowledge and experience in a regulated manufacturing environment.
• Excellent technical writing, communication, presentation, analytical, and project management skills.
• Experience with electronic document management systems required.
• SAP experience preferred.