Quality Operations Manager
We are seeking a Quality Operations Manager to join our Dun Laoghaire team at embecta, a global diabetes care company. As a key member of the quality leadership team, you will be responsible for ensuring our quality systems align with ISO standards and regulatory requirements.
Responsibilities:
* Quality Leadership: Be a key member of the Dun Laoghaire Quality Leadership Team and the site's extended leadership team.
* Team Management: Lead, inspire, and develop the Quality Engineering Team.
* Continuous Improvement: Partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies.
* System Oversight: Manage key quality system elements, including non-conformance processes, incident reporting, and customer complaint analysis.
* Quality Control: Oversee the activities of the Quality Control group.
* Drive Change: Lead key improvements in quality assurance and control systems.
* Collaborate Externally: Build strong relationships with external customers.
* Regulatory Excellence: Ensure timely and compliant completion of CAPAs.
* GMP Compliance: Provide oversight and ensure GMP standards are consistently met.
Education and Experience:
* A third-level qualification in Engineering or a Science discipline is required.
* 5+ years in an ISO 9001/2000 or ISO 13485 environment, ideally in Medical Devices or the Pharmaceutical industry.
* 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.
Why Join Embecta?
* Purpose-Driven Work: Make a tangible impact on the quality and safety of medical devices.
* Collaborative Environment: Work alongside passionate professionals in a culture that values teamwork and innovation.
* Career Growth: Take your career to the next level with opportunities for professional development and leadership.
embecta is an Equal Opportunity/Affirmative Action Employer.