Job Description SummaryAre you ready to make a difference in this world? Do you want to be part of a team that develops ground-breaking medical and biotechnology services and devices? One person can make a singular difference in saving and improving lives. At BD, we are looking for amazing, passionate and dedicated people like you. BD, a company standing on 120 years of innovation in medical technology, is currently recruiting talented individuals to join our new Research and Development (R&D) Centre of Excellence in Limerick. BD’s purpose is to advance the world of health. As part of our team, you will be on the forefront of creating and developing specialized devices, software solutions and systems to help others. Our new Centre in Limerick provides you with cutting edge technology and a creative environment to be inspired to tap into your inner genius. You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!
Reporting to the Site Quality Manager, the Quality Systems Engineer provides expertise on managing Quality System processes and related activities as per applicable requirements. They also ensure adequate level of controls / governance on training process related to Quality system elements for all Associates through proactive communication across organization, effective problem solving and active vigilance on applicable requirements and will drive compliance and effectiveness for QMS processes. Will also ensure regular reporting through key performance metrics to the Site Quality Manager. The Quality Systems Engineer is also expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined QMS strategy and related objectives.
As Quality Systems Engineer you will:
- Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485 / MDSAP certification
- Maintain the Quality Manuals and Quality Procedures and ensure content is compliant to applicable requirements and helps to maintain business agility.
- Lead change control activities within the site
- Analyse current and future procedural needs of the QMS
- Organise and manage the plant internal audit system and the corrective action reporting system Conduct Quality Systems audits and assist in training/guidance to other auditors
- Host external Quality System audits
- Provide training on Quality best practices and QMS processes
- Coordinate the review of Quality procedures associated with plant continuous improvement initiatives
- Develop quality training program as per site needs
- Coordinate quality data consolidation and reporting on Key Performance Indicators (KPIs) in order to drive continuous improvement across QMS.
The successful candidate will have a minimum level 8 degree in a Science related discipline along with a minimum of 5 years of relevant experience in the medical device industry. A strong knowledge of applicable regulations for Quality systems (ISO13485, 21CFR820) and the ability to collect data, analyse situations and propose optimal process solutions to meet both Compliance and Business requirements. They will have the capacity to work with Product Life-cycle Management system such as Agile / Document or Information system such as TrackWise or Learning Management System such as C2C.
Experience with quality tools and process improvement techniques, Lean Sigma certified or demonstrated problem solving experience and knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques are an advantage.
If you’re a team player who is passionate about ‘advancing the world of health’ and we’ve just described your career aspirations, then please click on the APPLY button where you will be directed to our website to apply directly.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/