Quality Engineer with CAPA and Test Method Validation (TMV)
- Full-time
Company Description
We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.
Job Description
Description:
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.
Thanks and Regards,
Mohammed Ilyas,
PH - 229-264-4029.
Additional Information
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