Quality Assurance Technician

Quality Assurance Technician Medical Device Manufacturing | Concord, CA About the Role The Quality Assurance Technician supports and maintains quality system processes within a regulated medical device manufacturing environment. This role ensures compliance with ISO 13485, FDA 21 CFR Part 820, cGMP, and applicable regulatory standards while supporting production quality activities across incoming, in-process, and final release stages. The ideal candidate is detail-oriented, knowledgeable in medical device quality systems, and capable of supporting audits, documentation control, investigations, and quality improvement initiatives in a fast-paced production environment. Responsibilities Coordinate and support quality system processes including: Nonconforming Material Reports (NCR) Corrective and Preventive Actions (CAPA) Complaint Handling Change Control Validation Programs Supplier Qualification and Monitoring Calibration Program Internal Audit Program Perform QA Final Release activities for incoming inspection, in-process inspection, and finished goods review. Interpret engineering drawings, specifications, and regulatory requirements. Assist with internal audits and support external audits including customer and third-party audits. Track and implement corrective actions resulting from audit findings. Ensure compliance with FDA, cGMP, ISO 13485, and medical device regulatory requirements. Maintain documentation and support quality records in accordance with regulatory standards. Utilize quality tools such as root cause analysis, Pareto charts, histograms, and flow diagrams. Support supplier quality initiatives and performance monitoring. Manage departmental inventories using purchase requisitions and material transfers. Collaborate cross-functionally with manufacturing, engineering, and operations teams. Provide training support and foster a quality-focused team environment. Qualifications Bachelor's degree in a related field preferred, or 1–2 years of experience in a regulated manufacturing environment. Working knowledge of ISO 13485 and FDA 21 CFR Part 820 Quality System Regulations. Familiarity with cGMP and medical device compliance requirements. Experience supporting CAPA, NCR, change control, or complaint investigations preferred. Ability to read and interpret technical drawings and regulatory documents. Strong analytical and problem-solving skills. Proficiency in Microsoft Office applications. Experience with quality tools and documentation systems preferred. Strong written and verbal communication skills. Physical & Work Environment In-person role within a regulated manufacturing facility. Ability to support production floor activities and inspection processes. #J-18808-Ljbffr Talnt