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Quality Engineer (Medical Device Industry)
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.
Kompensation & Benefits
A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.