Senior Quality Engineer - WMA

Job Title: Senior Quality Engineer Location: Devens, MA Location Type: On Site Website: Group: Watson-Marlow Fluid Technology Solutions, part of the Spirax Group, is a leading provider of fluid technologies for the life sciences and process industries. This role focuses on leading, developing, and maintaining quality validation, product qualification, and risk management programs for new product introduction and design & development quality. Responsibilities Manage sterility control and compliance programs; develop and implement QMS processes, procedures, templates, and records. Provide quality engineering guidance for NPI projects and ensure deliverables comply with regulatory and internal requirements. Collaborate with validation SME to verify and validate new products and processes during the NPI lifecycle. Investigate nonconformities using the eQMS Quality Event process, including product non‑conformances, process deviations, and customer complaints. Lead CAPA using structured data‑driven root cause analysis (5 Whys, Fishbone, FMEA). Assess design, product, and process changes for impact and risk, documenting and implementing per quality standards. Collaborate with cross‑functional teams to implement quality improvements aligned with WMFTS Quality Strategy. Support validation activities by developing and maintaining protocols and documentation in line with policy and processes; participate in internal audits, generating reports for improvement. Provide training, coaching and guidance on quality tools, systems, and best practices; promote a culture of quality and continuous improvement across functions. Other duties as assigned. Qualifications Bachelor’s degree in engineering or a scientific discipline. Minimum of 5 years experience in QA within a regulated industry. Proven knowledge of ISO 14644‑1, ISO 13485, and ISO 9001. Ability to host or co‑host ISO 9001 audits and customer audits. Strong communication and stakeholder engagement skills. Expertise in product and process validation methodologies. In‑depth understanding of the design and development lifecycle. Proficient in internal audits; lead auditor certification highly desirable. Track record in driving continuous improvement initiatives and applying lean methodologies. Advanced problem‑solving abilities, including root cause analysis and CAPA management. Excellent communication, planning, and organizational skills. Resilient and delivery‑focused; able to manage change in dynamic environments. Benefits Robust retirement plan: 5% employer 401K contribution plus a 50% match on up to 3% of employee contributions. Generous parental leave: 16 weeks at 100% pay; 6 months 80% work schedule with 100% pay. Generous time off: vacation, well‑being day, 9 observed holidays, 1 floating holiday, up to 15 caregiver days, 80 hours annual sick leave. Paid volunteer days: 3 per year. Healthcare plans with HSA contributions and comprehensive benefits. This position offers a salary range of $79,000 - $118,000 per year. Final salary offers vary based on education, experience, location, and candidate expertise. Equal Opportunity Employer Watson‑Marlow Fluid Technology Solutions is an Equal Opportunity Employer committed to diversity and inclusion. We prohibit discrimination or harassment on the basis of race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or other protected characteristics, in accordance with federal, state, and local laws. This policy applies to all employment practices within our organization. #J-18808-Ljbffr Watson-Marlow - North America