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

• Bachelors degree in a related field preferred or 12 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.