Senior Software Quality Engineer
Overview
The Senior Software Quality Engineer is accountable for supporting the Research Centre Ireland (RCI) site, RCI Project teams and/or other projects intended to enhance RCI’s operational effectiveness, including the initial creation of a Quality Management System for the RCI site. The Sr. Quality Engineer focuses on the creation of quality processes and procedures at the RCI site which support design control, process control & validation, supplier management and technology transfer based on industry and BD best practices.
We are the makers of possible
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.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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 health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
About The Role
The Senior Software Quality Engineer plays a pivotal role as an emerging Subject Matter Expert within cross-functional project teams, particularly in areas such as new product development, manufacturing transfer, and special initiatives. This role ensures that software-related deliverables meet customer expectations and comply with regulatory standards, including 21 CFR 820, 21 CFR 11, ISO 13485, ISO 14971, IEC 62304, IVDD 98/79/EEC, and EU MDR 2017/745. The engineer guides computer system validation efforts and assesses compliance with electronic records regulations, while overseeing key quality processes such as design planning, risk management, design reviews, and change control for both application and embedded software.
The Senior Software Quality Engineer reviews and approves critical documentation, including product drawings and verification/validation protocols. They apply statistical tools to analyse data, identify root causes, and drive effective problem resolution. This role is essential for maintaining product integrity and supporting continuous improvement across software development and quality functions.
Main Responsibilities
* Develop, enhance and maintain strategies and plans to improve the overall quality of software, including test coverage and system performance.
* Provide strategic and tactical support of the Quality Engineering Function, based on an understanding of 21 CFR Part 820 and ISO requirements.
* Owns and facilitates the Design Review and Functional Review Process for software products.
* Collaborate with Manufacturing and R&D to support software products, driving design improvements and monitoring measurable enhancements. Routinely interacts with multifunctional groups.
* Ensure BD PI Systems divisional, departmental policies, procedures, practices, and facilities are in compliance with applicable regulatory guidelines.
* Represent the Quality Function for New Product Development Core Teams and/or Technology Transfer Core Team.
* Serve as a core team member in software development projects handling requirements, software development planning, risk management, V&V, and related work.
* Remediate software-related audit findings and CAPAs.
About You
* Bachelor’s degree in Electrical, Mechanical, Software or Biomedical Engineering or another relevant technical field with 6 to 7 years of experience, or an MS/MBA with 7 years of experience (5 in software development or lifecycle management).
* Ability to manage multiple tasks and lead execution of change management plans.
* Experience in quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root cause analysis tools, and project management techniques.
* Strong written communications for clarity and audience consideration.
* Ability to communicate clearly and present points of view in one-on-one, group, and formal settings.
* Active listening skills for decision-making and problem-solving.
* Ability to use systematic analysis tools including root cause, failure analysis and risk assessment to gather information and diagnose issues.
* Drive for results and effectively navigate conflicts within teams by facilitating resolution.
* Working knowledge and understanding of FDA 21 CFR 820 and ISO standards.
Click on apply if this sounds like you!
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is typical to maintain our culture of excellence, with remote or field-based positions indicated in the posting.
Salary and Benefits
Salary Range Information: €54,800.00 - €93,200.00 EUR Annual
BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military status, or other legally protected characteristics.
For more information about BD, visit: https://bd.com/careers
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