Senior Quality Engineer

Watson-Marlow México; Harvard (MA); On-site; USD 85,000 - 107,000; Full time

Benefits offered by this job

Robust Retirement Plan

Parental Leave

Generous Time Off

Community Engagement Opportunities

3 healthcare plans with HSA

Job summary

Watson-Marlow Fluid Technology Solutions is seeking a Senior Quality Engineer to lead quality validation, product qualification, and risk management programs at the Devens site. You will ensure regulatory compliance and robust validation across the product lifecycle.

You will collaborate with Engineering, Manufacturing, and QA teams, driving CAPA and continuous improvement while supporting NPI and change management initiatives.

Qualifications

• Bachelor’s degree in engineering or science required.
• Minimum 5 years of Quality Assurance experience in a regulated industry.
• Proven knowledge of ISO 13485 and ISO 9001 standards.
• Excellent communication with cross-functional teams.
• Experience with product and process validation methodologies.
• Strong problem solving and CAPA management.

Responsibilities

• Lead, develop and maintain the site’s quality validation, product qualification and risk management programs.
• Support NPI and Design & Development Quality with technical oversight.
• Drive validation lifecycle control and regulatory compliance across production.
• Act as SME in quality validation, risk management and metrology.
• Lead internal audits and drive process improvements.
• Provide training and coaching on quality tools and systems.

Skills

Quality Assurance

ISO 13485

ISO 9001

Validation methodologies

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

Job Title: Senior Quality Engineer
Location: WMFTS - USA - Supply - Devens, MA
Location Type: On-Site
Website:https://www.wmfts.com/en/
Group:https://www.spiraxgroup.com/

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.

This role will focus on:

TheSenior Quality Engineer is responsible for leading, developing, and maintainingthe site’s quality validation, product qualification, and risk managementprograms, ensuring alignment with ISO standards, internal Quality ManagementSystems, and regulatory expectations. This role supports NPI (New ProductIntroduction) and Design & Development Quality, providing technicaloversight and quality governance on all activities including production toensure product safety, regulatory compliance, and robust validation lifecyclecontrol.

Acting as thesite’s subject matter expert (SME) in quality validation, risk management, andmetrology, the Senior Quality Engineer collaborates with cross-functionalstakeholders in Engineering, Manufacturing, R&D, Supply Chain, and QualityAssurance to drive consistent, compliant, and effective practices.

Key accountabilities include:

• Supervise your designated team.
• 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.
• Driveeffective Corrective and Preventive Actions (CAPA)through structured data drivenroot 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/Experience

• Bachelor’s degree in engineering, or a scientific discipline.
• Minimum of 5 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 organisational skills
• Resilient and delivery-focused, with a strong ability to manage change in dynamic environments

This position offers a salary range of USD $85,000 - $107,000. 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, empowering your 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.
• 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 atOur 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.