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Operations Excellence Manager

3 weeks ago


Galway, Galway, Ireland beBee Careers Full time

In this role as Operations Excellence Manager, you will be responsible for driving quality improvement initiatives, optimizing production efficiency, and reducing product defects. You will collaborate with cross-functional teams to develop and implement strategic plans for quality operations.

The ideal candidate will have extensive knowledge of quality management systems, statistical analysis, and risk management. They will also have experience in process validation, auditing, and managing corrective actions.

Key Responsibilities:

  • Drive quality improvement initiatives to optimize production efficiency and reduce product defects.
  • Collaborate with Operations, R&D, Regulatory, and Supply Chain teams to develop and implement strategic plans for quality operations.
  • Manage non-conformances, CAPA, risk management, and complaint handling processes.
  • Ensure compliance with FDA 21 CFR Part 820 and other applicable regulatory requirements.

Requirements:

  • Bachelor's degree in Engineering, Quality Management, or a related field.
  • Minimum of 7-10 years of experience in Quality Engineering or Quality Management within the medical device or regulated industry.
  • At least 3-5 years of experience in a leadership/management role.
  • Extensive knowledge of ISO 13485 and FDA 21 CFR Part 820.