Medical Device Quality Engineer

3 hours ago


Manchester, United Kingdom Merrimack Manufacturing Full time
Job Summary:

We are seeking a highly skilled Medical Device Quality Engineer to join our team at Merrimack Manufacturing. This role will be responsible for supporting design transfer activities and quality operations in an innovative, fast-paced medical device-manufacturing environment.

Main Responsibilities:
  • Generate and maintain control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity.
  • Lead project teams through protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release for use.
  • Investigate issues resulting in root cause and corrective actions through data analysis, inductive and deductive reasoning, and problem-solving skills.
Requirements:
  • Bachelor's degree in a relevant technical field; equivalent experience will be considered.
  • At least 3 years of experience in Medical Device Manufacturing or a similarly regulated industry.
  • Strong knowledge of CFR Part 820 and ISO 13485 required.
  • Estimated Salary: $80,000 - $110,000 per year.


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