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

Job Description Summary

Job Description

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!

The Design assurance QE is involved in new product development and product maintenance through the application of Quality engineering skills. Must be able to handle multiple projects and tasks, from product inception through product launch and maintenance utilizing a high level of written and oral communication skills. Plays an active role in the processes to ensure products meet quality standards consistent with both Corporate and division policies, while meeting all design controls, risk management, change control requirements and other applicable regulatory requirements. Represents the Quality Function on Project Teams for both new product development and existing products.

Main Responsibilities

  • Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .

  • Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.

  • Write project quality plans

  • Lead risk management activities within the project.

  • Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.

  • Assist / conduct Failure investigations and problem-solving sessions

  • Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.

  • Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.

  • Ensure process validation activities are completed appropriately and make the link with product design whenever needed.

  • Conduct quality functional reviews and DHF compliance reviews.

  • Be Design Assurance Quality Engineer on project core teams (PM, R&D, RA, Clinical, Marketing, Systems Engineering, Software Engineering) for design change projects and develop close relationship with other quality functions (plant quality engineering, Supplier quality assurance…) as needed for the project .

  • Be responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction. Adaptively apply working knowledge of quality engineering concepts within the product lifecycle.

  • Write project quality plans

  • Lead risk management activities within the project.

  • Participate within project core Teams to test protocol definition based on applicable specification and relevant requirements. Review and approve test protocol and reports. Review and approve related execution deviations.

  • Assist / conduct Failure investigations and problem-solving sessions

  • Review and challenge statistical rationale, plan and data analysis in the frame of test protocol / reports.

  • Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.

  • Ensure process validation activities are completed appropriately and make the link with product design whenever needed.

  • Conduct quality functional reviews and DHF compliance reviews.

  • Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485 / MDSAP certification

  • 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

  • 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.

Qualifications/Experience

  • The successful candidate will have a minimum level 8 degree in related discipline, with a minimum of 5 years of relevant experience and have proven expertise in design assurance including design controls and risk management (ISO 14971), reviewing and approving test protocols, SPC, experience working with Design History Files (ISO 13485, 21CFR820) and have experience working in the medical device sector.

  • Additional experience with Class III combination devices in a cleanroom environment, Capital equipment validation and reliability testing would be a distinct advantage.

  • The ability to collect data, analyze situations and propose optimal process solutions to meet both Compliance and Business requirements.

  • An individual in this role must have proven leadership, communication, organization and project management skills with a strong orientation on processes.

  • The ability to communicate efficiently in an international environment with internal / external customers and key stakeholders.

  • A strong working knowledge on managing life cycle documents and records. Deep understanding of change control and training process requirements.

Additional Qualifications/Experience

  • Capacity to work with Product Lifecycle Mangement system such as Agile / Documentum 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

  • Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques

  • Good communication skills

  • Technical writing skills

  • Fluent in English

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.

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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