Senior Quality Engineer - Plastics & Injection Molding

Job Description

Senior Quality Engineer – Plastics & Molding

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Location: North County San Diego, CA

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Company: Global healthcare and biopharmaceutical

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Benefits: Full benefits package

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Job Site : On-site

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Work Schedule: M-F; Day Shift

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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.

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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).

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Primary Responsibilities

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• 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.
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• Technical Expertise: Comprehensive knowledge of materials, formulations, and manufacturing processes specifically with injection molding and plastics.
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• Data & Project Management: Detail-oriented with strong data analysis capabilities using statistical software, combined with project management skills to handle competing deadlines.
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• 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.
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• Documentation & Specifications: Independently author, review, and approve raw-material specifications, quality agreements, and Supplier Quality Management System (SQMS) procedures.
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• 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.
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• Metrics & Continuous Improvement: Develop and trend Supplier Quality System metrics to identify opportunities for process enhancements and create department training programs.
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Knowledge, Skills, and Abilities

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

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Education

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

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

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