Supplier Quality Engineer

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.