Senior Quality Engineer: NPI, Validation & QMS Lead

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

Benefits offered by this job

Robust Retirement Plan

Parental Leave

Generous Time Off

Community Engagement Opportunities

3 healthcare plans with HSA

Job summary

Watson-Marlow Fluid Technology Solutions is seeking a Senior Quality Engineer to lead quality validation, product qualification, and risk management programs at the Devens site. You will ensure regulatory compliance and robust validation across the product lifecycle.

You will collaborate with Engineering, Manufacturing, and QA teams, driving CAPA and continuous improvement while supporting NPI and change management initiatives.

Qualifications

• Bachelor’s degree in engineering or science required.
• Minimum 5 years of Quality Assurance experience in a regulated industry.
• Proven knowledge of ISO 13485 and ISO 9001 standards.
• Excellent communication with cross-functional teams.
• Experience with product and process validation methodologies.
• Strong problem solving and CAPA management.

Responsibilities

• Lead, develop and maintain the site’s quality validation, product qualification and risk management programs.
• Support NPI and Design & Development Quality with technical oversight.
• Drive validation lifecycle control and regulatory compliance across production.
• Act as SME in quality validation, risk management and metrology.
• Lead internal audits and drive process improvements.
• Provide training and coaching on quality tools and systems.

Skills

Quality Assurance

ISO 13485

ISO 9001

Validation methodologies

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

Watson-Marlow Fluid Technology Solutions is seeking a Senior Quality Engineer to lead quality validation, product qualification, and risk management programs at the Devens site. You will ensure regulatory compliance and robust validation across the product lifecycle.

You will collaborate with Engineering, Manufacturing, and QA teams, driving CAPA and continuous improvement while supporting NPI and change management initiatives.