Senior Quality Engineer

Spirax-Sarco Ltd. • Devens, MA

11d • Onsite

About The Position

The Senior Quality Engineer is responsible for leading, developing, and maintaining the product’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 the product’s subject matter expert (SME) in quality validation, risk management, and metrology, the Senior Quality Engineer collaborates with cross-functional stakeholders in Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to drive consistent, compliant, and effective practices.

Requirements

• 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 14644-1; ISO 13485 and ISO 9001 standards.
• Ability to host or co-host ISO 9001 audits and customer audits.
• 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

Responsibilities

• Strong background in managing sterility control and compliance programs.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level