Quality Engineer: NPI, Validation & QMS Lead (On-Site)

Spirax Group; Harvard (MA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Robust Retirement Plan

Parental Leave program

Fertility Assistance

Generous Time Off

Volunteer days

Diverse Healthcare options

Job summary

Watson-Marlow Fluid Technology Solutions, part of the Spirax Group, is seeking a Quality Engineer to support quality validation, product qualification, and risk management across the site. You will ensure compliance with ISO standards and internal QMS, contributing to robust validation lifecycle control and regulatory alignment.

The role collaborates with Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance, driving improvements and ensuring product safety and quality governance

Qualifications

• Bachelor’s degree in engineering, or a scientific discipline.
• 2-3 years’ experience in Quality Assurance within a regulated industry.
• Strong knowledge of ISO 13485 and ISO 9001 standards.
• Ability to communicate effectively with cross-functional teams.
• Experience with validation methodologies and D&D lifecycle.
• Internal audits experience; lead auditor certification desirable.
• Proven track record in driving continuous improvement using lean methods.

Responsibilities

• Develop, implement, and sustain QMS processes including procedures, templates, and records.
• Provide QA guidance to NPI projects and change management.
• Collaborate on V&V of new products and processes in the NPI lifecycle.
• Investigate nonconformities via the eQMS Quality Event process.
• Lead CAPA activities with data-driven root cause analysis.
• Drive design, product, and process changes with risk assessment and documentation.
• Support validation protocols and documentation.
• Participate in internal audits and prepare audit reports.
• Provide training on quality tools, systems, and best practices.

Skills

Quality Assurance

Cross-functional communication

Lean methodologies

Problem-solving

Education

Bachelor’s degree in engineering or scientific discipline

Tools

eQMS

CAPA process

FMEA

Job description

Watson-Marlow Fluid Technology Solutions, part of the Spirax Group, is seeking a Quality Engineer to support quality validation, product qualification, and risk management across the site. You will ensure compliance with ISO standards and internal QMS, contributing to robust validation lifecycle control and regulatory alignment.

The role collaborates with Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance, driving improvements and ensuring product safety and quality governance