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IRL Limerick - Castletroy, Ireland
Onsite
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
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.
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.
Support Quality culture within R&D organisation while providing training on applicable requirements / standards.
About you
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 – advantage
Experience with IEC 62304 and IEC 62366 – advantage
Salary Range €55K - €70K
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
€56,600.00 - €86,300.00 EUR Annual