Quality Engineer
Posted on :
16-11-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1674285
Responsibilities:
- 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.
- Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience
- Test Method Validation (TMV)
- Corrective Action and Preventive Action (CAPA)
- Nonconforming Material Report (NCMR)
- Design of Experiments (DOE)
- 21 CFR820, ISO13485 and ISO14971
Employment Type
Full Time
Key Skills
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