Job Description
Job Title: Manufacturing EngineerJob Description
This role offers an opportunity for an experienced Manufacturing Engineer to drive compliance, quality, and efficiency in medical device manufacturing. You will focus on ensuring manufacturing processes meet EU Medical Device Regulation (EU MDR 2017/745) requirements and applicable quality and regulatory standards. The position centers on assessing, remediating, validating, and documenting manufacturing processes, while collaborating closely with Quality, Regulatory Affairs, R&D, Operations, and Supply Chain teams. You will lead process improvements, risk management activities, and technical documentation efforts to support ongoing regulatory compliance and robust manufacturing performance in a highly regulated environment.
Responsibilities
+ Support EU MDR compliance initiatives for legacy medical device products by reviewing and aligning existing manufacturing processes and documentation with current regulatory expectati...
This role offers an opportunity for an experienced Manufacturing Engineer to drive compliance, quality, and efficiency in medical device manufacturing. You will focus on ensuring manufacturing processes meet EU Medical Device Regulation (EU MDR 2017/745) requirements and applicable quality and regulatory standards. The position centers on assessing, remediating, validating, and documenting manufacturing processes, while collaborating closely with Quality, Regulatory Affairs, R&D, Operations, and Supply Chain teams. You will lead process improvements, risk management activities, and technical documentation efforts to support ongoing regulatory compliance and robust manufacturing performance in a highly regulated environment.
Responsibilities
+ Support EU MDR compliance initiatives for legacy medical device products by reviewing and aligning existing manufacturing processes and documentation with current regulatory expectati...
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