Quality Systems Specialist

Job Title: Quality Systems Specialist
Location: WMFTS - USA
- Supply
- Devens, MA
Location Type: On-Site
Website:
Group:

When you join Watson-Marlow Fluid Technology Solutions, a part of the Spirax Group, 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.

This role will focus on:

Who WeAre: Watson-Marlow Fluid Technology Solutions is part of Spirax Group, a FTSE
100 and FTSE4

Good 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:

This role sits within our Quality function. The Quality Systems specialist plays a critical role in governing quality processes, leading audits, ensuring ISO compliance, and embedding quality requirements across all site functions. The role acts as a quality subject‑matter expert, ensuring procedures, controls, and behaviors meet regulatory, customer, and corporate expectations. The position requires a strong understanding of regulated quality systems, exceptional documentation skills, and demonstrated internal auditing competency.

This role ensures the Quality is compliant, effective, and audit‑ready, and supports site certification efforts.

• Ensure the site Quality Management System complies with ISO standards, regulatory requirements, 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 expand.
• 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 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…