Senior Quality Engineer

Senior Quality Engineer

Location:

Devens, MA (On Site)

Job Summary:

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.

• Manage sterility control and compliance programs.
• Develop, implement, and sustain effective QMS processes, including procedures, templates, and quality records.
• Provide quality engineering guidance and support to NPI projects and change management, ensuring all quality deliverables are completed on time.
• 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 eQMS Quality Event process, including product non‑conformances, process deviations, and customer complaints.
• Drive 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.
• Participate in the internal audit team, conducting 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.
• Other duties as assigned.

• 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 management.
• Excellent communication, planning, and organisational skills.
• Resilient and delivery‑focused, with a strong ability to manage change in dynamic environments.

Salary range: $79,000 – $118,000 per year. Final salary offers are determined by multiple factors including education, experience, internal equity, geographic location, and the candidate’s expertise and may vary from the range listed. For roles based outside Massachusetts, the applicable salary range may be lower.

• Robust Retirement Plan – Employer 401(k) contribution of 5% plus a 50% match on up to 3% of your contributions.
• Comprehensive and supportive parental leave – 16 weeks at 100% pay and a gradual transition schedule upon return.
• Generous time off – vacation, well‑being days, 9 observed holidays, 1 floating…