Qualification Required

• Degree in Mechanical, Materials or Biomedical Engineering with years of experience

Roles And Responsibilities

• Hands on experience in Test Method Validation (TMV)
• Hands on experience 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

Required Technical And Professional Expertise: Medical Device, Quality, TMV (Test Method Validation), CAPA, NCMR, ISO13485.