embecta, formerly part of BD, 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 more than 2,000 employees around the globe. For more information, visit
Job Description Summary
Embecta, formerly part of BD, 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 more than 2,000 employees around the globe.
The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the BD organisation, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across operations, engineering, quality and R&D.
We are now looking for a Quality Engineer to join our Dun Laoghaire team.
Reporting to the Quality Operations Team Leader, duties will include active participation in Product & Process Development, Non-conformance investigations, lot disposition decisions, application of SPC to current production processes and liaison with key customers.
The role also involves coordination with QA/QC laboratories, approving of process validation studies, management of justified complaints investigations, and participation in change control processes and in process related adjustments and leading or participating in process improvement projects. You will prepare, review and approve technical documentation.
Main responsibilities will include:
- Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements;
- Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue;
- Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate;
- Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
- Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
- Review, analyze and report on relevant customer complaints and institute corrective actions.
The successful candidate will have previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry. The ideal candidate will hold a degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
You will have experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous). You will have experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise. You will manage and provide support with ongoing changes and continuous improvement projects e.g. Project Win SPC, automated machine.
This role requires the person to have previous experience of working in process validation and a clean room environment. You will have proven ability of working within a cross functional team and have excellent interpersonal and communication skills coupled with a high level of computer literacy.
Click on apply if this sounds like you!
For more information, visit .
Primary Work Location
IRL Dun Laoghaire – Pottery Road