Senior Quality Engineer | QMS, Validation & NPI Leader

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

Benefits offered by this job

401K plan

Parental leave

Paid time off

Job summary

Watson‑Marlow Fluid Technology Solutions, a part of Spirax Group, is seeking a Senior Quality Engineer to lead quality validation, product qualification, and risk management across the site. You will collaborate with Engineering, Manufacturing, R&D, and Supply Chain to ensure product safety and regulatory compliance throughout the NPI lifecycle.

The role requires expertise in ISO standards, internal audits, and CAPA management, with strong emphasis on validation activities and continuous

Qualifications

• Bachelor’s degree in engineering or scientific discipline.
• Minimum 5 years’ experience in Quality Assurance within a regulated industry.
• Proven working knowledge of ISO 13485 and ISO 9001 standards.

Responsibilities

• Lead and maintain the site’s quality validation, product qualification, and risk management programs.
• Provide quality governance on all activities including production to ensure safety and regulatory compliance.
• Drive CAPA through data-driven root cause analysis (5 Whys, Fishbone, FMEA).
• Develop and sustain QMS processes, procedures, and records.
• Support NPI projects with quality deliverables and change management.

Skills

Quality Assurance

ISO 13485

ISO 9001

Audit

CAPA

NPI

V&V

Lean

Root cause analysis

Communication

Change management

Education

Bachelor’s degree in engineering

Tools

eQMS

FMEA

5 Whys

Fishbone

Job description

Watson‑Marlow Fluid Technology Solutions, a part of Spirax Group, is seeking a Senior Quality Engineer to lead quality validation, product qualification, and risk management across the site. You will collaborate with Engineering, Manufacturing, R&D, and Supply Chain to ensure product safety and regulatory compliance throughout the NPI lifecycle.

The role requires expertise in ISO standards, internal audits, and CAPA management, with strong emphasis on validation activities and continuous