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.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.