Quality Systems Lead

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

Job summary

Waters Ireland Design Center is hiring a Quality Systems Lead to support medical device and IVD development while partnering with U.S.-based teams. You will be the site QMS expert, driving compliance, continuous improvement, and quality excellence across development and operations.

You will partner with Engineering, Regulatory Affairs, R&D, and facilities to support Design Controls, CAPA, audits, and change control.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a technical discipline.
• 8+ years of experience in a regulated industry (medical devices, diagnostics, pharma, or biologics).
• Strong knowledge of FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System.
• Ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR and other regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, R&D, and facilities.
• Support Design Verification, Design Validation, and Risk Management across the product lifecycle.
• Manage document control, training, change control, CAPA, audits, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through metrics and management reviews.
• Deliver quality training and promote a culture of compliance and continuous improvement.

Skills

Influence & relationship building

Decision making in complex env.

Communication

Problem solving

Project management

Education

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

Tools

TrackWise

Veeva

Agile PLM

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.

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.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System.
• Ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, 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/21 CFR 820, ISO 13485, ISO 14971, 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, Agile PLM, 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.

Equal Opportunity Employer

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.

Locations & Working Hours

Primary Work Location: IRL Limerick - Castletroy

Compensation & Benefits

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