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BD (Becton, Dickinson and Company) Quality Systems Engineer in Limerick, Ireland

Job Description Summary

Are 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!

Job Description

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/

Primary Work Location

IRL Limerick - Castletroy

Additional Locations

Work Shift

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.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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