eqms jobs in San Diego

Senior D365 IT Business Systems Analyst supporting the configuration, implementation, and ongoing maintenance of a Microsoft Dynamics 365 ERP system focused on Manufacturing and Supply Chain functions. The role involves liaising with business departments (Inventory, Manufacturing, Planning, QA/QC, Purchasing), analyzing requirements, configuring solutions, managing data quality, and coordinating testing and change management across a highly integrated system.…See more Requires 3–5 years of ERP implementation experience (D365, Oracle, or SAP) and strong cross-functional communication skills to bridge technical, business, and vendor teams.

Quality Assurance Specialist II leads and supports audit activities, serves as a QA subject matter expert during inspections, and manages quality events and risk assessments for medical device products. The role involves conducting root cause analyses, managing document control and training workflows, coordinating the internal audit program, and driving quality-system improvement projects.…See more The position requires a bachelor's degree in a scientific or engineering discipline with 3–5 years of QA or regulatory affairs experience in a regulated industry, with medical device experience highly preferred. Key responsibilities include compliance with ISO 13485 and 21 CFR Part 820, partnership with senior quality engineers on risk management, and eQMS implementation and validation.

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.