Clean Room Operator
On-siteAustin, Texas, United States
Job Summary
Develop inspection sheets for implants, instruments, and components; draft first article inspection sheets and create overlays for optical comparators. Run, analyze, and publish reports on site quality metrics while performing receiving, in-process, and final inspections. Interpret engineering drawings and GD&T requirements using calipers, micrometers, gauges, and CMM equipment. Manage nonconforming material, participate in Material Review Board activities, and support structured problem-solving efforts including 5 Whys, 8D, and RCA. Apply statistical techniques such as SPC, Cp, and Cpk to drive continuous improvement and ensure product reliability. Support internal and external audits and corrective/preventive actions. Requires 2+ years of experience in regulated manufacturing; full-time work authorization in the US required.
Required Qualifications
- Minimum of 2 years of related experience and/or training
- Demonstrated ability to use computers effectively, including strong working knowledge of Microsoft
- Proficiency in mechanical inspection techniques and inspection equipment
- Experience tracking tasks, actions, or projects and following up to completion
- Ability to communicate clearly and professionally in written and verbal English
- Must be able to lift 35 lbs
- Must be able to stand long periods of time
- Must be able to bend, twist and lift overhead
- Must be able to pack & unpack boxes
- Applicants must already have full-time work authorization in the United States, both now and in the future, without requiring sponsorship
Desired Qualifications
- Associate or bachelor's degree in engineering, science, or a related technical field (preferred but not required)
- Strong attention to detail with excellent analytical skills
- Experience in a regulated manufacturing environment (medical device experience is a plus)
- Ability to work collaboratively in a team-based environment
- Working knowledge of SolidWorks and overlay creation/printing
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