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Quality Operations Manager
1 month ago
We are a global diabetes care company leveraging our 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions and partnerships.
Quality Operations Manager RoleWe are seeking a passionate quality professional to lead and drive excellence as our next Quality Operations Manager.
Responsibilities- Quality Leadership: Be a key member of the Dun Laoghaire Quality Leadership Team, ensuring our quality systems align with ISO standards and regulatory requirements.
- Team Management: Lead, inspire, and develop the Quality Engineering Team, fostering collaboration, delegation, and performance excellence.
- 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, ensuring seamless integration and high performance.
- Drive Change: Lead key improvements in quality assurance and control systems, championing innovation and operational excellence.
- Collaborate Externally: Build strong relationships with external customers, ensuring their needs and expectations are met.
- Regulatory Excellence: Ensure timely and compliant completion of CAPAs, maintain high-quality documentation, and prepare for audits with confidence.
- GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
- A third-level qualification in Engineering or a Science discipline is required; a postgraduate qualification in a related area is a plus.
- 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 (Greenbelt Certification is a bonus).
- Knowledge of FDA requirements and experience managing FDA audits.
- Experience with process validation, sterilization, and clean room environments is advantageous.
Purpose-Driven Work: Make a tangible impact on the quality and safety of medical devices that improve lives. 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. Commitment to Excellence: Be part of a company that is dedicated to upholding the highest standards in everything we do.
Embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
