Quality Assurance Technician
Job Summary: 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
Qualifications Guidelines: Any combination equivalent to, but not limited to, the following:
- High school diploma or equivalent. Experience with Medical or related industry preferred.
- Knowledge/Skills/Abilities: Demonstrated knowledge of Metrology and Inspection Technique.
- Ability to use hand tools, calibrated instruments, measurement equipment, microscopes, and testing fixtures.
- Basic understanding of Quality System Regulation
- Expertise in Microsoft Office applications
- Excellent written and verbal communication and interpersonal skills
- Ability to prioritize and organize work independently.
- Flexible and comfortable in fast paced work environment
- Proficiency with written and spoken English