Medical Device Quality Engineer
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Accentuate Staffing is partnered with a growing medical device company to hire a Quality Engineer focused on Design Assurance. This person will need to have a strong understanding of ISO 13485 and will be the regulatory guardian of the device design process! This is a great opportunity for someone with an entrepreneurial spirit to build a product from the ground up in a fast paced environment.
Responsibilities:
- Provide support and oversight for the medical device product design and activities surrounding it
- Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
- Ensure documentation of traceability of requirements through design output and to design verification and/or design validation.
- Drive project teams towards early requirements maturation, early test plan/script development, and design input requirements that are indicative of real-world use case environment and customer needs.
- Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
- Support the CAPA process by performing investigation, root cause analysis and verification of effectiveness checks for design related issues.
- Support internal and external regulatory and customer audits.
- Participate in the improvement of the manufacturing process for existing products as needed.
- Lead regulatory efforts for product clearances both within the US and outside the US.
Requirements:
- BS Degree in Engineering
- 5+ years’ experience in medical device design and development
- Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485
- Experience with 510K and EU CE clearances is preferred.
