Sr Quality Specialist Document Control

Waters; Macclesfield; Hybrid; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Flexible working arrangements

25 days' holiday

Generous pension contribution

Private medical insurance

Life assurance and income protection

Excellent family-friendly benefits

Ongoing development and career growth

Job summary

Waters Corporation is seeking a Senior Quality Specialist to own Document Control and the Document Management System within a regulated environment. You will drive compliance with ISO 9001/13485 and FDA, ensuring data integrity and efficient processes.

You will lead automation and AI-enabled improvements, collaborate with global teams on QMS initiatives, and support audits and regulatory inspections while fostering a culture of operational excellence.

Qualifications

• Experience with ISO 9001 and ISO 13485 in a regulated environment.
• Proven track record in managing electronic document management systems.
• Experience supporting audits, regulatory inspections, and compliance programmes.
• Experience leading quality improvement initiatives and process optimisation.
• Strong analytical, problem-solving and stakeholder management skills.

Responsibilities

• Own the Document Control and Document Management System.
• Drive compliance with ISO 9001/13485, FDA and related requirements.
• Lead automation, digital tools and AI-enabled improvements for document lifecycle management.
• Collaborate with global teams on QMS initiatives and audits.
• Coach colleagues to build quality capability and drive a proactive culture.

Skills

Quality systems

Document control

Data analysis

Stakeholder management

Continuous improvement

Education

Engineering/Science degree

Job description

Shape the future of Quality at Waters Corporation.

Are you passionate about quality systems, continuous improvement, and using technology to drive smarter ways of working? Join Waters Corporation, a global leader in analytical technologies and medical devices, and help transform how quality is delivered across our organisation.

As our Senior Quality Specialist, you'll take ownership of Document Control and our Document Management System, leading the evolution of key quality processes while championing digital and AI-enabled solutions. This is an opportunity to make a real impact by improving compliance, efficiency, and user experience across a highly regulated environment.

Working closely with local and global stakeholders, you'll play a key role in strengthening our Quality Management System, supporting business growth, and embedding a culture of operational excellence.

Responsibilities

What You'll Be Doing

In this role, you'll become the go-to expert for Quality System Guidance, Document Control and the Document Management System, ensuring compliance with ISO 9001, ISO 13485, FDA, and other regulatory requirements.

You'll lead the development and continuous improvement of document control processes, driving greater efficiency and effectiveness across the business. A key focus will be identifying opportunities to modernise the function through automation, digital tools, and AI-enabled solutions that enhance document lifecycle management and data integrity.

You’ll also collaborate with global teams on Quality Management System initiatives, support audits and regulatory inspections, investigate quality system issues, analyse performance metrics, and coach colleagues to build quality capability and foster a proactive quality culture.

Qualifications

What We're Looking For

You may have a degree or HND in Engineering, Science, or a related discipline, or equivalent experience gained within a regulated environment.

To be successful, you'll bring:

• Strong knowledge of ISO 9001, ISO 13485, 21 CFR Part 820 and Part 11
• Experience managing and improving electronic document management systems
• A track record of supporting audits, regulatory inspections, and compliance programmes
• Experience leading quality improvement, business transformation, or process optimisation initiatives
• Strong analytical, problem-solving, and decision-making skills
• Excellent communication and stakeholder management abilities
• A passion for continuous improvement and driving positive change

Experience implementing automation, digital technologies, or AI-driven process improvements would be particularly valuable.

Why Join Waters?

At Waters, you'll be part of an innovative organisation where quality, technology, and continuous improvement go hand in hand. You'll have the opportunity to influence global processes, work alongside talented colleagues, and contribute to projects that make a real difference.

Alongside a competitive salary, we offer:

• Flexible working arrangements
• 25 days' holiday
• Generous pension contribution
• Private medical insurance
• Life assurance and income protection
• Excellent family-friendly benefits
• Ongoing development and career growth opportunities

If you're ready to combine quality expertise with innovation and digital transformation, we'd love to hear from you.

Company Description

Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, our innovative portfolio harnesses deep scientific expertise across chemistry, physics, and biology. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Through a shared culture of relentless innovation, our passionate team of ~16,000 colleagues turn scientific challenges into breakthroughs that improve lives worldwide.

Diversity and inclusion

Diversity and inclusion are fundamental to our core values at Waters Corporation. It benefits our employees, our products, our customers and our community. Waters complies with all applicable federal, state, and local laws. Qualified applicants are considered without regard to sex, race, color, ancestry, national origin, citizenship status, religion, age, marital status (including civil unions), military service, veteran status, pregnancy (including childbirth and related medical conditions), genetic information, sexual orientation, gender identity, legally recognized disability, domestic violence victim status, or any other characteristic protected by law. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. All hiring decisions are based solely on qualifications, merit, and business