Specialist - Quality Assurance

The Quality Assurance Specialist supports the Quality Management System (QMS) by ensuring products, processes,

and documentation comply with applicable regulatory requirements, internal procedures, and quality standards. This

role assists in inspections, documentation control, complaint handling, and quality system maintenance to ensure

product safety and effectiveness.

Primary Job Responsibilities

• Complaint Handling Support
• Assist with intake, documentation, and processing of customer complaints
• Support complaint investigations and ensure timely closure
• Help ensure complaints are evaluated for reportability

Inspection and Testing

• Perform incoming, in-process, and final inspections of components and finished devices
• Verify product conformity to specifications, drawings, and procedures
• Record inspection results and ensure proper documentation in batch records (DHRs)

Assist with the compiling and reporting of quality and regulatory metrics

Training Support

• Ensure training records are maintained and up to date
• Support onboarding and training documentation for new employees

Other duties may be assigned by manager.