Quality Systems Specialist

About the role

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.

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 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 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

Requirements

• 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

Qualifications

• Experience in a similar role
• Knowledge of relevant industry standards and regulations
• Technical proficiency in quality management systems
• Effective communication and interpersonal skills
• Problem-solving and decision-making capabilities

Skills

• Quality management systems
• ISO compliance
• Internal auditing
• Documentation and record-keeping
• Regulatory compliance
• Training and mentoring
• Collaboration and teamwork
• Root cause analysis
• Improvement initiatives

Benefits

At Watson-Marlow Fluid Technology Solutions, we offer a comprehensive benefits package designed to support your well-being and professional growth. This includes:

• A robust retirement plan with a 5% employer match and a 50% match on up to 3% of your contributions
• A comprehensive and supportive parental leave policy
• A generous time-off policy with ample vacation and well-being days, 9 observed holidays, 1 floating holiday day, up to 15 caregiver days, and 80 hours of annual sick leave
• Community engagement opportunities with 3 paid volunteer days each year
• Additional benefits such as health insurance plans with HSA contributions

Pay

The salary range for this role is USD 55,420.00 - 83,130.00 Salaried. Final salary offers are determined by multiple factors, including education, experience, internal equity, geographic location, and the candidate’s expertise, and therefore may vary from the range listed. For roles based outside Massachusetts, the applicable salary range may be lower.

Schedule

Details regarding the work schedule will be provided during the interview process.