Quality Operations Manager
This role is a critical leadership position at embecta, a global diabetes care company, where you will be at the heart of our mission to maintain the highest standards of quality, compliance, and continuous improvement.
About Us
embecta is a purpose-driven organization that values your opinions and contributions. We empower our employees to bring their authentic self to work and foster an inclusive, growth-centered, and rewarding culture.
Your Role
You will lead the Quality Engineering Team, fostering collaboration, delegation, and performance excellence through regular reviews and goal-setting. You will partner with production teams to drive continuous improvement initiatives using Six Sigma methodologies and manage key quality system elements.
Main Responsibilities
1. Quality Leadership: Ensure our quality systems align with ISO standards and regulatory requirements.
2. Team Management: Lead, inspire, and develop the Quality Engineering Team.
3. Continuous Improvement: Drive change and champion innovation in quality assurance and control systems.
4. System Oversight: Manage non-conformance processes, incident reporting, and customer complaint analysis.
5. Quality Control: Oversee the activities of the Quality Control group and ensure seamless integration and high performance.
6. Collaborate Externally: Build strong relationships with external customers and ensure their needs are met.
7. Regulatory Excellence: Ensure timely and compliant completion of CAPAs and maintain high-quality documentation.
8. GMP Compliance: Provide oversight and ensure GMP standards are consistently met in production and quality engineering activities.
Education and Experience
We require a third-level qualification in Engineering or a Science discipline, with 5+ years in an ISO 9001/2000 or ISO 13485 environment. You should have supervisory experience and a proven track record of team development, as well as experience preparing technical documentation and managing CAPA systems.
Why Join Us?
1. Purpose-Driven Work: Make a tangible impact on the quality and safety of medical devices that improve lives.
2. Collaborative Environment: Work alongside passionate professionals in a culture that values teamwork and innovation.
3. Career Growth: Take your career to the next level with opportunities for professional development and leadership.
4. Commitment to Excellence: Be part of a company that is dedicated to upholding the highest standards in everything we do.
EEO Employer Statement
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of protected status.