gmp jobs in San Diego

This Quality Assurance Engineer role supports medical device product development and sustaining engineering teams by developing and implementing quality test procedures, test equipment protocols, and sampling plans. The engineer will conduct product investigations, corrective/preventive actions, regulatory submissions support, and statistical analysis of production data—all in compliance with industry standards (ISO 14971), GMP, and regulatory requirements.…See more The role requires 4+ years in medical device/pharmaceutical quality engineering or equivalent advanced degree with 2+ years of relevant experience, with expertise in test method validation, equipment qualification (IQ/OQ/PQ), risk management documentation, and analytical equipment validation.

The Quality Assurance Specialist II independently owns and operates defined Quality Management System processes, serving as a subject matter expert for batch release, NCMR/deviation/CAPA management, and asset control. The role requires judicious decision-making on routine and moderately complex quality and compliance matters, including investigating quality events, driving corrective actions, and supporting regulatory submissions and FDA inspections.…See more The specialist works collaboratively with a QA Associate and Sr. Quality Systems Engineer, leading process improvements and providing escalation support with minimal oversight.

Lead compliance testing and certification activities for a portfolio of medical devices, developing test strategies, managing external laboratories and certification bodies, and ensuring products meet FDA, safety, EMC, wireless, and regulatory requirements. Partner with Engineering, Quality, and Regulatory Affairs to identify compliance risks early and drive mitigation strategies.…See more Manage a team of compliance engineers and test professionals, oversee departmental budgets, and continuously improve compliance testing processes and best practices.

This Quality Assurance Specialist II role supports clinical trial projects at a pharmaceutical CDMO, ensuring compliance with cGMP and SOPs throughout the product lifecycle. Responsibilities include pre- and post-execution batch record review, authoring/updating QA and compliance documentation, participating in investigations and deviation writing, and reviewing change controls.…See more The candidate must demonstrate strong knowledge of GMP environments, proficiency with MS Office (especially Excel) and ERP systems like JD Edwards, and 5–10+ years of relevant pharmaceutical QA experience depending on education level.