1. Perform medical device assembly, processing and packaging per SOP, cleanroom rules, QMSR and ISO13485 requirements.
2. Complete accurate, traceable production records and comply with FDA data integrity standards.
3. Conduct in-process self-inspection; stop work and report any quality abnormality or non-conforming products immediately.
4. Operate, clean, and perform daily checks on production equipment and tools.
5. Handle materials properly to avoid mix-up and contamination.
6. Maintain workplace 5S and cleanroom standards, and support internal and external audits.
Job Qualifications:
1. High school diploma or equivalent.
2. Cleanroom or medical device manufacturing experience preferred.
3. Able to understand basic English work instructions and willing to learn QMSR compliance rules.
4. Detail-oriented, disciplined, and able to follow standard work procedures.
5. Good vision; able to adapt to factory schedule and overtime as needed.
6. Legally authorized to work in the United States.
7. Bilingual in English and Spanish
Principals only. Recruiters, please don't contact this job poster.