Software Quality Engineer II

Becton Dickinson; Limerick; On-site; EUR 45,000 - 68,000; Full time

Job summary

Becton Dickinson is seeking a Quality Engineer to support Software Quality Design Assurance for UCC products in Limerick, Ireland. You will drive quality across the product lifecycle, from development to maintenance, ensuring design control, risk management, and regulatory compliance.

The role requires strong communication, teamwork, and leadership in cross-functional teams. You will contribute to continuous improvement and ensure product quality aligns with corporate policy and medical device

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

Responsibilities

• 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.
• Represents the Quality Function on Project Teams for both new product development and existing products.

Skills

Quality engineering

Leadership on teams

Design verification

Software validation

Risk management

Regulatory knowledge

Education

Bachelor's Degree in Science, Technology, Engineering, or Mathematics, or relevant equivalent qualification

Job description

We are the people who give possibilities purpose 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.

Job Description 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)
• Drivers 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

Why Join Us?

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.

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

Primary Work Location IRL Limerick - Castletroy Additional Locations Work Shift

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.

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 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.