Job Description

JOB SUMMARY:

The R + D Quality Engineer III leads and enforces product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.

ESSENTIAL/PRIMARY DUTIES:

  • Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO:, ISO:, ISO, FDA, CSA, and EU MDR regulations.
  • Leads all risk management processes and creates risk management documentation for (NPD) projects.
  • Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.
  • Facilitates the design and process failure mode and effects analysis (FMEA) process.
  • Leads site-based quality depa...

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