Quality Systems Lead

Becton Dickinson; Limerick; On-site; EUR 85,000 - 90,000; Full time

Job summary

Waters Ireland Design Center is seeking a Quality Systems Lead to drive the site’s Quality Management System and align development activities with global regulatory standards. You will collaborate with Engineering, Regulatory Affairs, and R&D to ensure compliant processes across design controls, risk management, and change control.

The role demands at least 8 years in a regulated field, strong knowledge of FDA QMSR/21CFR820, ISO13485, IVDR, and hands-on experience with electronic QMS tools.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
• Strong knowledge of FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.
• Ability to influence, build effective working relationships, and make sound decisions in complex environments.
• Experience using electronic quality management systems such as TrackWise, Veeva, AgilePLM, SAP, or Windchill, combined with strong communication, problem-solving, and project management skills.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site’s Quality Management System.
• Ensure compliance with FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and other applicable regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, Research & Development, and facility management teams.
• Support Design Verification, Design Validation, and Risk Management activities throughout the product development lifecycle.
• Manage key quality processes, including document control, training, change control, CAPA, audit management, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through quality metrics, management reviews, and performance assessments.
• Deliver quality training and promote a culture of compliance, continuous improvement, and accountability.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Auditing

Project management

Education

Bachelor's degree in Engineering, Life Sciences, or another technical discipline

Tools

TrackWise

Veeva

AgilePLM

SAP

Windchill

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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

Join our Ireland Design Center as a Quality Systems Lead, where you will play a key role in supporting medical device and IVD product development activities while partnering with U.S.-based Legal Manufacturer teams. As the site’s Quality Management System (QMS) expert, you will drive compliance, continuous improvement, and quality excellence across development and operational processes. In this individual contributor role, you will maintain and enhance the site’s QMS, ensuring alignment with global quality standards and regulatory requirements. You will work closely with cross-functional teams to support product development, risk management, audit readiness, and ongoing compliance initiatives that contribute to the delivery of safe and effective healthcare solutions.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site’s Quality Management System.
• Ensure compliance with FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and other applicable regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, Research & Development, and facility management teams.
• Support Design Verification, Design Validation, and Risk Management activities throughout the product development lifecycle.
• Manage key quality processes, including document control, training, change control, CAPA, audit management, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through quality metrics, management reviews, and performance assessments.
• Deliver quality training and promote a culture of compliance, continuous improvement, and accountability.

Preferred Requirements

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
• Strong knowledge of FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.
• Ability to influence, build effective working relationships, and make sound decisions in complex environments.
• Experience using electronic quality management systems such as TrackWise, Veeva, AgilePLM, SAP, or Windchill, combined with strong communication, problem-solving, and project management skills.

Salary range for the role: €85.000 to €90.000 per annum

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. 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

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. 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 €75,900.00 - €115,725.00 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.