BD (Becton, Dickinson and Company) Quality Engineer in Dun Laoghaire, Ireland
Job Description Summary
Reporting to the Quality Engineering Manager, Dun Laoghaire, duties will include management and execution of process validation studies, active participation in non-conformance investigation, process improvement projects, project management, application of SPC to current production processes and liaison with key customers.
Our facility in Dun Laoghaire has recently completed a large expansion plan and now produces the majority of pen needles for the diabetes market globally. We are now ramping up to commence producing the newest BD product to support the diabetes market here onsite. With all these exciting developments taking place we are recruiting a Quality Engineer within the Quality/Validation Team.
The Quality Engineering role here at the plant here in Dun Laoghire is to provide collaborative support to process development and project engineering to assure compliance with all BD quality policies, procedures and practices through consistent application of sound quality engineering / assurance principles.
As Quality Engineer your responsibilities are to include:
The Quality Engineer on this project/new product will be the key Quality Engineering representative ensuring that all activities within the development and validation lifecycle adhere to both BD and regulatory requirements.
Development of control plans
Ensure design transfer activities are carried out such that all product design requirements are satisfied in a controlled manner through to shop floor introduction.
Be a key driver of cGMP practices within Operations and Quality divisions
Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems
Responsible for ensuring adherence to all BD and external regulatory requirements
Become an active member of the site internal audit team, liaising with Regulatory auditors
Prepare and maintain documentation in compliance with the appropriate regulatory requirements
Support production personnel in relevant continuos improvement activities (Six Sigma etc.)
Act as customer liaison contact for given key customers as appropriate.
This position is a key team member for process development cross functional teams to ensure that process development is carried out using the correct statistical methods. The successful candidate will 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. The ideal candidate will hold a primary 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 statistical process control and six sigma methodologies (Greenbelt Certification would be advantageous).
You will have experience in CAPA system mgmt and a working knowledge of FDA requirements and managing FDA audits. 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. interact with all levels of colleagues and bring cross team working to its fullest potential.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Primary Work Location
IRL Dun Laoghaire - Pottery Road
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.