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.