Senior Quality Engineer

Senior Quality Engineer – Devens, MA (On-Site)

Job description:

The Senior Quality Engineer will lead, develop, and maintain the site’s quality validation, product qualification, and risk management programs, ensuring alignment with ISO standards, internal Quality Management Systems, and regulatory expectations. The role supports NPI (New Product Introduction) and Design & Development Quality, providing technical oversight and governance on all activities from design to production to ensure product safety, regulatory compliance, and robust validation lifecycle control.

Acting as the site’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.

• Supervise the designated team.
• Develop, implement, and sustain effective quality management system (QMS) processes, including 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 ensure 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 the eQMS Quality Event process, including product nonconformances, 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.

• Bachelor’s degree in engineering, or a scientific discipline.
• Minimum of 2 years’ experience supervising a Quality Assurance team.
• 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 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 management.
• Excellent communication, planning, and organisational skills.
• Resilient and delivery‑focused, with a strong ability to manage change in dynamic environments.

USD $79,237 – $100,000 (based on education, experience, geography, and expertise). For roles based outside Massachusetts, the applicable salary range may be lower.

• Robust Retirement Plan
  : 5% employer 401(k) contribution, plus a 50% match on up to 3% of employee contributions.
• Comprehensive Parental Leave
  : 16 weeks at 100% pay; post‑return 80% work schedule with 100% pay for 6 months.
• Generous Time Off
  : vacation, well‑being days, 9 observed holidays, 1 floating holiday, up to 15 caregiver days, and 80 hours of annual…