Quality Systems Specialist

Quality Systems Specialist Location: WMFTS - USA - Supply - Devens, MA Location Type: On‑Site Website: Group: 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. 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. Other duties as assigned. 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. Salary This position offers a salary range of 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. Benefits Robust Retirement Plan: Benefit from a 5% employer 401K contribution, plus a 50% match on up to 3% of your contributions. Comprehensive and Supportive Parental Leave: inclusive, gender‑neutral parental leave policy, offering 16 weeks at 100% pay, with gradual transition and continued pay. Generous Time Off: vacation, well‑being day, 9 observed holidays, 1 floating holiday day, up to 15 caregiver days, and 80 hours of annual sick leave. Community Engagement Opportunities: 3 paid volunteer days each year. Health Care: 3 healthcare plans with HSA contributions and other benefits. Equal Opportunity Employer Watson‑Marlow Fluid Technology Solutions is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or other protected characteristics as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Watson‑Marlow Fluid Technology Solutions makes hiring decisions based solely on qualifications, merit, and business needs at the time. #J-18808-Ljbffr Watson-Marlow - North America