Senior Quality Engineer – NPI & Validation Lead

Watson-Marlow México; Massachusetts; Hybrid; USD 85,000 - 107,000; Full time

Benefits offered by this job

401K with match

Parental leave

Generous time off

Volunteer days

Healthcare plans

Job summary

Watson-Marlow Fluid Technology Solutions is seeking a Senior Quality Engineer at WMFTS USA to lead quality validation, risk management, and product qualification across the development lifecycle. You will partner with Engineering, Manufacturing, and QA to ensure regulatory alignment and robust changes.

The role requires 5+ years in quality within regulated industries, strong ISO 13485/9001 expertise, and proven NPI involvement, with a focus on design and development quality and V&V activities.

Qualifications

• Minimum 5 years’ experience in Quality Assurance within a regulated industry.
• Proven knowledge of ISO 13485 and ISO 9001 standards.
• Strong ability to engage with cross-functional stakeholders.
• Experience in product and process validation methodologies.
• Understanding of design and development lifecycle.

Responsibilities

• Lead, develop, and maintain quality validation, product qualification, and risk management programs.
• Provide technical oversight for NPI and Design & Development Quality.
• Support validation activities and ensure quality deliverables are compliant.
• Drive CAPA through root cause analysis and data-driven actions.
• Collaborate with Engineering, Manufacturing, Supply Chain, and QA to implement improvements.

Skills

Quality Assurance

ISO 13485

ISO 9001

NPI

Design & Development

CAPA

Risk Management

Cross-functional Collaboration

Education

Bachelor’s degree in engineering or scientific discipline

Tools

eQMS

Internal audits

Job description

Watson-Marlow Fluid Technology Solutions is seeking a Senior Quality Engineer at WMFTS USA to lead quality validation, risk management, and product qualification across the development lifecycle. You will partner with Engineering, Manufacturing, and QA to ensure regulatory alignment and robust changes.

The role requires 5+ years in quality within regulated industries, strong ISO 13485/9001 expertise, and proven NPI involvement, with a focus on design and development quality and V&V activities.