embecta is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of approximately 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and  Twitter .

The Quality Operations Manager will lead the Quality Operations Team in Dun Laoghaire. They will also play a pivotal role in site process improvement activities and be the central point of contact for key customers. Duties will include management and approval of process validation studies, project management, application of SPC to current production processes and liaison with key stakeholders.

Responsibilities

• Provide support for relevant ISO Quality Systems.

• Responsible for ensuring adherence to all embecta, external and appropriate regulatory requirements.

• Become a key member of the Dun Laoghaire Quality Leadership Team

• Support production personnel in relevant continuous improvement activities (Six Sigma).

• Day to day Leadership/Management of Quality Engineering Team. Manage and develop the team through involvement, delegation, and regular reviews of performance as established in goals.

• Management of Key quality systems elements relating to direct production support such as the non-conformance system, incident reporting system and customer complaint analysis.

• Management of Quality control, engineering and validations group and their activities.

• Driving key changes and improvements in the Quality assurance and control systems.

• Liaise with key external customers.

• Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments

• Prepare and Maintain documentation in compliance with appropriate regulatory requirements.

• Supporting key changes and improvements in manufacturing relating to product quality.

• GMP oversight and compliance of Production and Quality Engineering activities.

• Supporting key changes and improvements in manufacturing relating to product quality

• Any other reasonable duties which may be required by management from time to time

Educational Requirements:

• Third level qualification in an Engineering or Science Discipline.

• A postgraduate qualification in a related area would be advantageous.

Relevant Experience:

• 5+ years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.

• 3+ years supervisory experience.

• Experience in the preparation of Technical Documentation.

• Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).

• Experience in CAPA system management.

• A working knowledge of FDA requirements and managing FDA audits.

• Experience in process validation, Sterilisation and working in a clean room environment would be advantageous.

• Proven ability of working in a cross-functional team environment.

• Excellent interpersonal and communication skills and high level of computer literacy.