Quality Assurance Technician

Quality Control Technician

The Quality Control Technician is responsible for the verification of purchased product, incoming inspection of purchased materials, and finished goods acceptance. Quality system requirements are effective in accordance with 21 CFR 820, ISO 13485 for Medical Devices, and international regulations as applicable.

Reporting to: Quality Manager, Quality Engineers

Examples of Essential Functions: Including but not limited to:

• Perform receiving inspection activities for material conformance, product inspection, and review of lot history records.
• Perform in-process quality inspection of assembled medical devices.
• Observes and enforces Controlled Environment Room/Cleanroom Protocols.
• Creates and maintains quality Records for components and materials used in the production of medical devices. Observes and enforces good documentation practices, as well as ensuring full traceability of material origin.
• Adheres to general safety policies, company policy, manufacturing procedures, training requirements, and applicable standards/regulations for the production of medical devices.
• The identification, control, and release of materials that do not conform to specification.
• Work with engineers to improve component specifications and recommend actions to prevent occurrence of non-conformities.
• Calibrates measurements tooling and equipment as needed