Senior Quality Engineer - Plastics & Injection Molding

Senior Quality Engineer – Plastics & Molding

Location: North County San Diego, CA

Company: Global healthcare and biopharmaceutical

Benefits: Full benefits package

Job Site : On-site

Work Schedule: M-F; Day Shift

Global healthcare company in North County San Diego, CA is seeking a Senior Quality Engineer- Plastics & Molding . In this role, you will function as a primary quality lead on cross-functional teams focusing on new materials, supplier qualifications, and supplier changes.

You will be responsible for developing and updating material specifications to ensure correct, compliant internal and external standards, regulations, and requirements are integrated into the Quality Management System (QMS).

Primary Responsibilities

• Supplier Audits & Qualification: Apply a risk-based approach to create and execute the annual supplier audit program, provide team guidance, and independently conduct internal and external audits. Develop qualification programs for new materials and suppliers.
• Technical Expertise: Comprehensive knowledge of materials, formulations, and manufacturing processes specifically with injection molding and plastics.
• Data & Project Management: Detail-oriented with strong data analysis capabilities using statistical software, combined with project management skills to handle competing deadlines.
• Risk & Nonconformance Management: Define and monitor supplier risk levels using risk-assessment tools. Oversee vendor notification processes, manage Supplier Corrective Action Requests (SCARs), investigate root causes, and provide technical assessments on resolution effectiveness.
• Documentation & Specifications: Independently author, review, and approve raw-material specifications, quality agreements, and Supplier Quality Management System (SQMS) procedures.
• Change Control & Regulatory Support: Act as a Subject Matter Expert (SME) on supplier change notifications, assessing impact on product quality and the QMS. Host third-party audits from regulatory bodies (FDA, notified bodies) and business partners.
• Metrics & Continuous Improvement: Develop and trend Supplier Quality System metrics to identify opportunities for process enhancements and create department training programs.

Knowledge, Skills, and Abilities

• Technical Writing: Exceptional writing skills with proven experience independently drafting SOPs, forms, risk assessments, and technical documentation.
• Communication & Presentation: Strong cross-functional communication skills with the ability to convey complex ideas clearly and present information effectively to all organizational levels.
• Compliance: Demonstrated knowledge of Good Manufacturing Practices (GMP).

Qualifications

Education

• Minimum Requirement: Bachelor's degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or a related technical field.

Experience

• Quality Assurance: Minimum of 8 years of relatable work experience in QA is preferred.
• Supplier Management: Minimum of 5 years of prior experience in Supplier Management is preferred.
• Domain Expertise: Direct hands-on experience in injection molding and plastics (including direct expertise, manufacturing, maintenance, or quality).
• Software & Systems: Required prior experience working with an electronic document management system. Experience with SAP, trend analysis, and change implementation is a strong plus.

Occupational Demands

• Travel: Varies based on business needs, with potential for frequent local site visits and occasional travel within the United States.