Quality Technician II – Critical Medical Components/Devices
About The Position
As a Quality Technician, you’ll be responsible for performing detailed inspections and functional tests on critical components and/or finished medical devices. This role is focused on inspection and testing—requiring precision, consistency, and a solid understanding of medical device standards. You’ll work closely with Quality Engineers and Production to proactively identify gaps to compliance, verify documentation, and support continuous improvement. This position will play a very active role on the floor in support of daily operations and manufacturing execution. This role will support our growth on our 2nd shift and will work Monday through Friday, 4:30pm-3am. (4-10 hour shifts)
Requirements
- Minimum 3–5 years of quality technical experience in the medical device industry required.
- Proven experience inspecting critical or high-precision components and/or devices.
- Familiarity with ISO 13485, and Good Documentation Practices (GDP)
- Proficiency with inspection equipment and interpreting engineering drawings and GD&T
- Experience using Excel, electronic QMS platforms (e.g., Minitab, ETQ, Master Control), and document control systems
- Excellent attention to detail, organization, and communication skills
Nice To Haves
- CQI or CQT certification
- Experience with cleanroom manufacturing in a medical device setting.
- Working knowledge of SPC and data analysis tools such as Minitab
- Familiarity with Failure Investigation techniques.
Responsibilities
- Perform dimensional and visual inspections on critical medical device components or assemblies using various measurement tools like calipers, micrometers, vision inspection equipment, gauges, etc.
- Conduct functional tests and verify conformance to detailed specifications and tolerances
- Interpret engineering drawings, specifications, and work instructions
- Record and maintain accurate inspection data, including lot history and traceability records
- Support lot release, material review, and root cause analysis for nonconforming parts
- Participate in audits and provide complete, well-organized inspection documentation
- Assist in implementing corrective actions and reinforcing compliance with ISO 13485 and FDA regulations
- Ensuring adherence to GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) requirements
- Nonconformance, CAPA, and Material Review Board Support
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
501-1,000 employees
