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Quality Excellence Director

1 week ago

Dublin, Dublin City, Ireland Brightwater Full time

About the Company

Brightwater is a multinational medical device company that delivers innovative solutions to improve quality of life.

Position Overview

We seek a Quality Operations Manager to lead our Quality Leadership Team, ensuring alignment with ISO standards and regulatory requirements.

Responsibilities:

  • Be a key member of the Quality Leadership Team and the site's extended leadership team.
  • Lead, inspire, and develop the Quality Engineering Team.
  • Partner with production teams to drive continuous improvement initiatives.
  • Manage key quality system elements.
  • Oversee the Quality Control group.
  • Drive change by leading key improvements in quality assurance and control systems.
  • Buil strong relationships with external customers.
  • Ensure timely and compliant completion of CAPAs.
  • Provide oversight and ensure GMP standards are consistently met.

Qualifications:

  • A third-level qualification in Engineering or a Science discipline.
  • 5+ years in an ISO 9001/2000 or ISO 13485 environment.
  • At least 3 years of supervisory experience with a proven track record of team development.
  • Experience preparing technical documentation and managing CAPA systems.
  • Familiarity with Statistical Process Control and Six Sigma methodologies.
  • Knowledge of FDA requirements and experience managing FDA audits.
  • Experience with process validation, sterilization, and clean room environments is advantageous.
  • Strong interpersonal and communication abilities.
  • Exceptional problem-solving and analytical skills.
  • High-level computer literacy and the ability to work effectively in cross-functional teams.