Quality Operations Team Leader
Job Description SummaryWe are recruiting for a Quality Operations Leader on a permanent basis on our site in Dun Laoghaire. In this role you will be a key member of the Dun Laoghaire Quality Leadership Team.
BD, also known as Becton Dickinson, provides pen needles for the care of Diabetes patients globally. The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the BD organization, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across Operations, Engineering, Quality and R&D.
We are recruiting for a Quality Operations Leader on a permanent basis on our site in Dun Laoghaire. In this role you will be a key member of the Dun Laoghaire Quality Leadership Team.
The Quality Operations Leader will 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. Other Key duties will involve leading and directing the Quality Engineering team.
- To provide support for ISO9000/ISO13485 Quality System.
- Responsible for ensuring adherence to all BD, external and appropriate regulatory requirements.
- 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 IIGs (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 group and their activities.
- Driving key changes and improvements in the Quality assurance and control systems.
- 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
For this role you will hold a Third level qualification in an Engineering or Science Discipline or have a postgraduate qualification in a related area would be advantageous. You must have a minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
You will also need a knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous) and experience in process validation, Sterilisation and working in a clean room environment would be advantageous.
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Primary Work LocationIRL Dun Laoghaire - Pottery Road
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