QMS Specialist

Spirax Group plc

Devens, MA

JOB DETAILS
SKILLS
Analysis Skills, Auditing, Best Practices, Biology, Calibration, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Control, Document Management, Documentation, ISO (International Organization for Standardization), Industrial Engineering, Internal Audit, Interpret Regulations, Maintain Compliance, Mentoring, Operations Processes, Organizational Skills, People Management, Performance Metrics, Problem Solving Skills, Production Control, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk, Risk Management, Root Cause Analysis, Source Code/Configuration Management (SCM), Staff Training, Supply Chain, Team Player, Technical Writing, Training/Teaching, Vendor/Supplier Evaluation, Vendor/Supplier Management, Writing Skills
LOCATION
Devens, MA
POSTED
30+ days ago

Who We Are Watson-Marlow Fluid Technology Solutions is part of Spirax Group, a FTSE100 and FTSE4Good multi-national industrial engineering Group with expertise in the control and management of steam, electric, thermal solutions, peristaltic pumping, and associated fluid technologies. When you join us, you will be integrated into a cooperative and encouraging team, participate in challenging yet critical work, and experience ongoing growth opportunities to help you achieve your full potential. Visit our website to learn more.

Role Summary The Quality Systems Lead is responsible for designing, implementing, and maintaining the sites Quality Management System (QMS) to meet ISO requirements. This role leads the internal and customer audit program, authors and revises QMS documentation, and drives compliance across all functions. The position requires a strong understanding of regulated quality systems, exceptional documentation skills, and demonstrated internal auditing competency. This role ensures the QMS is compliant, effective, and audit-ready, and supports site certification efforts.

What Youll Be Doing

  • Design, draft, and implement QMS processes, procedures, and templates compliant with ISO regulatory expectations and corporate quality policies.
  • Maintain control of QMS documentation, ensuring structure, version control, and alignment with best practices and site needs.
  • Collaborate with cross-functional SMEs to ensure procedures reflect operational reality while meeting regulatory requirements.
  • Support creation and maintenance of Quality Manuals, process maps, and QMS frameworks consistent with ISO expectations.
  • Own the internal audit schedule and ensure full QMS coverage annually.
  • Develop audit plans, criteria, scope, and checklists for process, system, and regulatory audits.
  • Conduct audits independently and objectively across all organizational functions.
  • Gather and evaluate objective evidence to assess compliance with QMS and regulatory requirements.
  • Document findings, classify nonconformities, and issue audit reports in alignment with internal standards.
  • Track and verify corrective actions through closure, ensuring effectiveness.
  • Train and mentor internal auditors as the program expands.
  • Lead gap assessments between current practices and ISO requirements.
  • Drive site readiness for certification and customer audits.
  • Ensure all QMS elements (design control, calibration, risk management, training, document control, production control, CAPA, and supplier quality) are implemented and audited appropriately.
  • Participate in management reviews by preparing QMS performance metrics and compliance summaries.
  • Partner with the Quality Control team to investigate quality system nonconformities and identify systemic gaps.
  • Provide guidance on root-cause analysis and effectiveness verification.
  • Recommend and champion quality system improvements using audit outcomes and risk-based methodologies.
  • Provide training to employees on QMS processes, documentation, audit readiness, and quality system expectations.
  • Collaborate with cross-functional roles (Engineering, Production, Supply Chain, Quality Control) to ensure seamless implementation of QMS requirements.
  • Serve as the on-site expert for QMS structure and ISO interpretation.
  • Supervise the site Document Control & Training Coordinator.
  • Other duties as assigned.

Who Youll Be Working With All levels of the organisation.

This Is What Youll Need to Be Successful in This Role

  • Bachelors degree in Life Sciences, Engineering, Quality, or related discipline.
  • Formal internal auditor or lead auditor training.
  • Experience implementing or auditing QMS compliant systems is highly desirable.
  • Strong working knowledge of quality system elements: document control, training, risk management, CAPA, supplier management, validation, and production controls.
  • Excellent written communication and technical writing skills.
  • Ability to interpret regulations and translate them into practical procedures.
  • High integrity, objectivity, and ability to challenge stakeholders constructively.
  • Strong analytical, organizational, and problem-solving skills.
  • Ability to work independently and lead compliance activities across multiple departments.

About the Company

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Spirax Group plc