Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryBE PART OF SOMETHING BIGGER!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 70,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our Research and Development (R&D) Centre of Excellence in Limerick provides cutting edge technology and a creative environment to be inspired to tap into your inner genius. We are looking for amazing, passionate and dedicated people like you, where you will be at the forefront of creating and developing specialised devices, software solutions and systems to help others. You are the one who can make the difference. Join us and be a crucial part of advancing the world of health!
Our vision for Medication Management Solutions at BD
With our technical capabilities, the Medication Management Solutions (MMS) team are able to manage multiple systems and our operational capabilities enable us to have medications available when and where needed, reducing inefficiency and waste for nursing and pharmacy teams.
About the role
As Design assurance QE you will be involved in new product development and product sustaining projects through the application of Quality engineering skills. You will handle multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.
You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements. The Design Assurance QE represents the Quality Function on Project core teams for both new product development and existing products.
Main responsibilities will include:
- Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with other quality functions as needed for the project.
- Write project quality plans and support the creation and maintenance of DHF documentation
- Lead risk management activities within the project.
- Support the creation and implementation of verification and validation activities
- Review and approve test protocol and reports.
- Review and challenge statistical rationale, and data analysis in the frame of test protocol and reports.
- Review and approve related execution deviations.
- Assist / conduct Failure investigations and problem-solving sessions
- Review quality objectives and goals that have been identified and ensure they are sufficiently defined in specifications, procedures, and testing.
- Conduct quality functional reviews and DHF compliance reviews.
- Ensure compliance across projects for design control, risk management, and change control processes.
- MDR specific needs:
- Ensure state of the art requirements are correctly applied
- Ensure design controls standards are applied within the program (DDP/QP, Phase-gate etc.)
- Collaborate with stakeholders (in/out of MDR) to ensure appropriate MDR decisions are made
- Create MDR compliant risk files ensuring file is up to date with state of the art standards
- Support DHF evidence review as required
- Support Quality culture within R&D organisation while providing training on applicable requirements / standards.
- A relevant degree (engineering degree- preferred) or equivalence of minimum 3 years of quality engineering experience
- Knowledge in working with ISO 13485, QSR, ISO 14971, statistical techniques
- Strong written and verbal communication skills
- Strong organisational skills
- Experience with MDR
- Experience with IEC 62304 and IEC 62366 – advantage
Click on apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Becton, Dickinson and Company is an Equal Opportunity 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, or any other protected status.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work LocationIRL Limerick - Castletroy
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory