Software Quality Engineer II

BD; Limerick; On-site; EUR 70,000 - 100,000; Full time

Job summary

BD is seeking a Quality Engineer to support software quality design assurance for medical devices. The role involves applying Quality engineering skills to new product development and maintenance, from inception to launch, while ensuring compliance with design controls, risk management, and change control processes.

You will collaborate with R&D and cross-functional teams, lead investigations, and drive continuous improvement initiatives to meet corporate and regulatory requirements.

Qualifications

• Bachelor's degree in Science, Technology, Engineering, or Mathematics or equivalent.
• Extensive knowledge of Medical Device standards and regulations incl. ISO 13485, ISO 14971, FDA QSR, IEC 62304, IEC 62366.
• Ability to implement systemic changes to improve product quality and efficiency.
• Experience with Design Verification, Design Validation, Test Method Validation, and Software Validation.

Responsibilities

• Participates on Project Teams as Quality Representative.
• Ensures Design Control principles are applied to product/process changes and new product development.
• Leads quality initiatives for products across the life cycle.
• Creates, reviews, and approves risk management files (RMM, Hazard Analysis, FMEA).
• Leads failure investigations and CAPA plans for continuous improvement.
• Creates, reviews, and approves design/verifications, validations, and related reports.
• Develops and improves Quality System documents (CAPA, Audits, Risk Management, Design Control).
• Drives quality planning for new product development and maintenance.
• Supports training on applicable standards and requirements.

Skills

Quality engineering

Regulatory knowledge

Risk management

FMEA

Design control

Communication

Education

Bachelor's degree in Science/Engineering

Tools

CAPA system

Risk management software

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).
• 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.

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.