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Limerick, Éire / Ireland
Onsite
Not Available
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.
Main Responsibilities
• Participates on Project Teams as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
• Lead Quality Initiatives for products that include the entire product life cycle
• Creates, reviews, and approves Risk Management Files documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s
• Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects
• Creates, reviews, and approves Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations
• Creates, reviews, and improves Quality System Documents (CAPA, Audits, Risk Management, Design Control)
• Drives Quality Planning for New Product Development
• Assist / conduct Failure investigations and problem-solving sessions
• Ensure compliance across projects for design control, risk management and change control processes. Support Quality culture within R&D organization while providing training on applicable requirements / standards
Duties / Accountabilities:
This role will be supporting Software Quality Design Assurance for UCC Products. The 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.
Qualifications
• Bachelor's Degree in Science, Technology, Engineering, or Mathematics, or relevant
equivalent qualification
• Extensive knowledge of Medical Device standards and regulations including ISO 13485, ISO 14971, FDA regulations QSR, IEC 62304 Medical device software life cycle and IEC 62366 Usability
• Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency
• Expertise in Design Verification, Design Validation Process, Test Method, and Software
Validation for Medical Devices
• Ability to participate and provide leadership on teams and maintain positive work
environment with those teams. Understands team functions, leadership technique, time management, project management methodologies and able to balance multiple task assignments
• Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience
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
€44,800.00 - €68,350.00 EUR Annual