Senior Quality & Document Control Lead — AI-Driven

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

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.