Position- Quality Engineer
Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience
- Hands on experience in Test Method Validation (TMV)
- Hands on experience (at least 2 yrs) in Manufacturing related CAPA Activities
- Hands on experience in Production Non-conformance (NCMR's)
- Working independently with the internal and external stakeholders for execution.
- Provides Quality Engineering support for commercial Medical products.
- Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
- Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
- Present technical data to groups within and outside the organization.
Job Type: Full-time
Pay: $70.00 - $73.00 per hour
Benefits:
- Health insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- Remote
Work Location: Remote
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