Quality Systems Specialist

Job Title: QMS Specialist Location: US Supply - Devens 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. 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 site’s 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 You’ll 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 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 ISO interpretation. Supervise the site Document Control & Training Coordinator. Other duties as assigned. Who You’ll Be Working With All levels of the organisation. This is what you’ll need to be successful in this role Bachelor’s 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. 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. At Watson‑Marlow, we believe in taking care of our colleagues. Robust Retirement Plan: Benefit from a 5% employer 401K contribution, plus a 50% match on up to 3% of your contributions for added financial security. Comprehensive and Supportive Parental Leave: Experience our inclusive, gender‑neutral parental leave policy, offering 16 weeks at 100% pay. Upon your return, enjoy a gradual transition with a unique 80% work schedule while still receiving 100% of your pay for the first 6 months. Generous Time Off: Enjoy ample time off to recharge and attend to life's circumstances with generous vacation and 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: Make a difference with 3 paid volunteer days each year, encouraging you to give back to the community and causes you care about. And Many More Benefits: Such as an offering of 3 healthcare plans with HSA contributions along with other benefits designed to support your well‑being and professional growth. We invite you to explore all the ways we strive to create a fulfilling and rewarding work environment. Everyone is Included at Spirax Group We are passionate about creating inclusive and equitable working cultures where everyone can be themselves and achieve their full potential. For us, that means supportive teams and strong relationships where everyone’s contribution is valued across social and cultural backgrounds, ethnicities, ages, genders, gender identities, abilities, neurodiversity, sexual orientation, religious beliefs, and everything else that makes us human and unique. We know that everyone needs some extra help from time to time, so we have introduced a range of additional benefits through our Group Inclusion Commitments. Learn more at Our Inclusion Commitments . 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. Company Overview At Watson‑Marlow Fluid Technology Solutions, we are driven by innovation and are dedicated to creating an inclusive workplace where everyone is empowered to make a difference. As a world leader in manufacturing peristaltic pumps and associated fluid path technologies for the life sciences and process industries, we offer a wide range of products, including tubing, specialised filling systems and products for single‑use applications. Watson‑Marlow 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. Our purpose is to create sustainable value for all our stakeholders as we engineer a more efficient, safer and sustainable world. Our technologies play an essential role in critical industrial processes and industrial equipment across industries as diverse as Food & Beverage, Pharmaceutical & Biotechnology, Power Generation, Semiconductors and Healthcare. With customers in 165 countries, we provide the solutions that sit behind the production of many items used in daily life, from baked beans to mobile phones! Our inclusive culture and values, unites us, guides our decisions and inspires us everywhere that we operate. We support our colleagues to make their difference for each other as well as customers, communities, suppliers, our planet and shareholders by creating a truly equitable working environment where everyone feels included. #J-18808-Ljbffr Watson-Marlow - North America