supplier-qualification jobs in San Diego

This role leads quality engineering strategy and operations for a medical device design center, overseeing compliance with FDA regulations (21 CFR 820, ISO 13485, ISO 14971) and managing a team of Quality Engineers. The manager develops and sustains quality management systems, executes quality initiatives, provides statistical and design-control expertise, and drives continuous improvement.…See more The position requires ten years of progressive QA experience in FDA-regulated industries, three years of direct management experience, and deep knowledge of design controls, risk management, and quality engineering methodologies.

The QA Associate II supports quality assurance operations in a regulated manufacturing environment, ensuring materials, processes, and products comply with cGMP and company procedures. Responsibilities include reviewing batch records and analytical data, assessing deviation and CAPA closure, conducting GMP documentation reviews and line clearance inspections, and supporting material/equipment qualification and audit activities.…See more The role requires independent judgment on routine quality decisions, cross-functional collaboration with Manufacturing, QC, and other departments, and the ability to draft and revise SOPs and quality documentation. A Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment are required; cell therapy, aseptic technique, and cleanroom experience are valued.

The QA Associate II reviews manufacturing batch records, analytical test results, and quality documentation to ensure compliance with cGMP and company procedures. Responsibilities include assessing deviations and CAPAs, conducting line clearance inspections and process observations, supporting material and equipment qualification, and participating in audits and investigations.…See more The role requires judgment in routine and moderately complex quality decisions, cross-functional collaboration, and SOP documentation in a regulated biopharmaceutical manufacturing environment.

QA Associate II supports manufacturing operations at a cell-therapy biotech company, reviewing batch records, analytical results, and quality documentation to ensure compliance with cGMP and company procedures. The role involves assessing deviations and CAPAs, conducting line clearance inspections, performing GMP documentation reviews, and supporting material/equipment qualification and audit activities.…See more The person will exercise judgment on routine and moderately complex quality issues, escalate concerns appropriately, and collaborate cross-functionally with Manufacturing, QC, and Facilities. The position requires a Bachelor's degree in biological sciences and minimum 2 years of GMP manufacturing experience in a regulated environment.

Staff Quality Engineer for a medical device manufacturer responsible for owning and continuously improving the Quality Management System across the full product lifecycle. The role involves coordinating QMS processes and documentation, leading design control programs, managing change control reviews, directing CAPA activities, handling complaints and supplier qualification, and leading internal audit programs.…See more Requires 8–10+ years of medical device quality experience, 3+ years in quality system auditing, and strong expertise in ISO quality systems and FDA-regulated device standards.

Staff-level quality engineer responsible for new product introduction (NPI) of semiconductors and PCIe/server infrastructure for AI data centers. Will represent quality engineering across core development teams, drive reliability and supplier readiness, manage AQL sampling and non-conforming material disposition, and own product quality end-to-end from development through high-volume manufacturing.…See more Must lead corrective actions, supplier qualification, and risk mitigation while interfacing with customers and suppliers. Requires bachelor's degree in computer science or electrical engineering with 4+ years of hardware engineering experience (or equivalent advanced degree with less experience).