Job Description
We’re seeking a Medical Device Quality Engineer to join our team! In this role, you will be responsible for the monitoring and maintenance of the company's QMS as well as participating in the design and development of spinal system devices. Candidates must be willing to take a lead role in performing all work necessary to ensure compliance to regulations and company procedures. Training and mentoring will be provided.
Responsibilities:Support the maintenance of the Quality Management System, in compliance with various U.S. and international Quality System regulations including 21 CFR Parts 803, 806, & 820; ISO 13485:2016; and ISO 14971:2019.
Monitor the health and compliance of the QMS to internal procedures.
Calculate and review quality system metrics against published goals.
Generate data to support Management Reviews.
Lead CAPA investigations, implementation, and effectiveness monitoring.
Perform complaint investigations and support Medical Device Reporting activities.
Write and review engineering changes (ECNs).
Oversee all Document Control processes.
Support the Receiving Inspection department.
Review Device History Records.
Write and review NCRs.
Write and review rework instructions.
Support the creation of tool specifications and assist with the review of calibration records.
Maintain supplier files and the Approved Supplier List.
Calculate supplier performance for supplier scorecards.
Manage Supplier Corrective Actions (SCARs).
Support new product development activities by generating and reviewing design control deliverables.
Maintain an understanding of all product development & sustaining engineering projects.
Maintain Design History Files.
Coordinate with the CTO to support all regulatory submissions.
Support internal and external audits.
Ensure that employees properly understand and implement Genesys Spine’s procedures.
Qualifications:
Bachelor's degree in engineering, medical sciences, or relevant field (3 years Quality experience in medical devices or pharmaceutical field may be applied in lieu of educational requirement).
Be well versed in 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and related international regulatory standards.
Genesys Spine designs, develops, and sells medical devices for spinal fusion. We have over 25 FDA cleared spinal systems on the market with more in development. We invest in our employees to allow for growth, development, and career advancement.
Genesys Spine designs, develops, and sells medical devices for spinal fusion. We have over 25 FDA cleared spinal systems on the market with more in development. We invest in our employees to allow for growth, development, and career advancement.
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