Quality Systems Lead — ISO Compliance & Audit Expert

Watson-Marlow México; Massachusetts; Hybrid; USD 55,000 - 83,000; Full time

Benefits offered by this job

Robust Retirement Plan

Parental Leave

Generous Time Off

Volunteer days

Healthcare plans with HSA

Job summary

Watson-Marlow Fluid Technology Solutions in Devens, MA is seeking a Quality Systems Specialist to govern quality processes, lead audits, and ensure ISO compliance across site functions.

The role requires strong documentation skills, internal auditing competency, and collaboration with Engineering, Production, and Supply Chain to embed QMS requirements and prepare for audits and certification.

Qualifications

• Quality background within manufacturing
• Experience implementing, maintaining, and/or auditing ISO‑compliant Quality Management Systems
• Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline
• Formal internal auditor or lead auditor training
• 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

Responsibilities

• 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 ISOrequirements
• 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
• Collaborate with Quality Control 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 to ensure seamless implementation of QMS requirements
• Serve as the on‑site expert for QMS structure and ISOinterpretation
• Supervise the site Document Control & Training Coordinator
• Other duties as assigned

Skills

Quality systems

ISO compliance

Internal auditing

Documentation

Education

Bachelor's degree in Life Sciences/Engineering/Quality

Job description

Watson-Marlow Fluid Technology Solutions in Devens, MA is seeking a Quality Systems Specialist to govern quality processes, lead audits, and ensure ISO compliance across site functions.

The role requires strong documentation skills, internal auditing competency, and collaboration with Engineering, Production, and Supply Chain to embed QMS requirements and prepare for audits and certification.