Quality Engineer

Quality EngineerThe Quality Engineer is responsible for support the development, and maintenance of the site's quality validation, product qualification, and risk management programs, ensuring alignment with ISO standards, internal Quality Management Systems, and regulatory expectations. This role supports NPI (New Product Introduction) and Design & Development Quality, providing technical oversight and quality governance on all activities including production to ensure product safety, regulatory compliance, and robust validation lifecycle control.Acting as a member of the site's subject matter expert (SME) team responsible for quality validation, risk management, and metrology, the Quality Engineer collaborates with cross-functional stakeholders in Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to drive consistent, compliant, and effective practices.Key accountabilities include:Develop, implement, and sustain effective quality management system (QMS) processes, including the creation and control of procedures, templates, and quality records.Provide quality engineering guidance and support to New Product Introduction (NPI) projects, and as part of change management ensuring all quality deliverables are completed on time and in compliance with regulatory and internal requirements.Work closely with the validation technical SME to ensure effective verification and validation (V&V) of new products and processes within the NPI lifecycle.Champion thorough investigation of nonconformities using our eQMS Quality Event process, including product non-conformances, process deviations, and customer complaints.Drive effective Corrective and Preventive Actions (CAPA) through structured data driven root cause analysis (e.g., 5 Whys, Fishbone, FMEA).Drive improvements in design, product, and process changes by ensuring changes are impact and risk assessed, documented and implemented in line with quality standards.Collaborate with cross-functional teams (Engineering, Manufacturing, Supply Chain, Quality) to implement quality improvements, in line with the WMFTS Quality Strategy.Support validation activities by ensuring the development and maintenance of validation protocols, procedures, and documentation in line with policy and process.Be part of the internal audit team, conducting and generating audit reports to drive process improvements.Provide training, coaching and guidance on quality tools, systems, and best practices to colleagues and stakeholders.Promote a culture of quality, continuous improvement, and risk-based thinking throughout the product lifecycle and across all functions.Other duties as assigned.Skills/ExperienceBachelor's degree in engineering, or a scientific discipline.Minimum of 2-3 years' experience in Quality Assurance within a regulated industry.Proven working knowledge of ISO 13485 and ISO 9001 standards.Strong ability to engage and communicate effectively with cross-functional stakeholders.Demonstrated expertise in product and process validation methodologies.In-depth understanding of the design and development lifecycle.Proficient in conducting internal audits; lead auditor certification is highly desirable.Established track record in driving continuous improvement initiatives and applying lean methodologies.Advanced problem-solving capabilities, including root cause analysis and effective CAPA (Corrective and Preventive Action) management.Excellent communication, planning, and organizational skillsResilient and delivery-focused, with a strong ability to manage change in dynamic environmentsThis position offers a salary range of (USD 85,000.00 - 105,000.00 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. We offer a generous benefits package, including: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, ensuring a balanced reintegration into the workplace.Fertility Assistant Program: Fertility Benefits to support you on your journey to building a family. It may include IVF, genetic testing, and other fertility-related services.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 GroupWe 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 EmployerWatson-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 OverviewAt 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.