Quality Engineer - NPI, Validation & CAPA Lead

Watson-Marlow México; Harvard (MA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

5% employer 401K match

Parental leave

Fertility benefits

Generous time off

Volunteer days

Healthcare plans

Job summary

Watson-Marlow Fluid Technology Solutions is seeking a Quality Engineer to support the site’s quality validation, product qualification, and risk management programs in a regulated environment.

You will collaborate with cross-functional teams across Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to ensure product safety and regulatory compliance throughout the validation lifecycle.

Qualifications

• Bachelor’s degree in engineering or a scientific discipline.
• Experience in quality assurance within a regulated industry.
• Strong knowledge of ISO 13485 and ISO 9001.

Responsibilities

• Develop, implement, and sustain effective QMS processes with procedures and quality records.
• Provide quality guidance to NPI projects and manage change compliance.
• Collaborate on V&V of new products and processes within the NPI lifecycle.
• Lead investigations of nonconformities using CAPA and root cause analysis.
• Drive improvements through change management and risk assessment.

Skills

Quality Assurance

Regulated industry

Cross-functional communication

Lean methodologies

Root cause analysis

CAPA

Project management

Quality validation

Risk management

Auditing

Education

Bachelor’s degree in engineering or science

Tools

eQMS

FMEA

GMP

Audit tools

Job description

Watson-Marlow Fluid Technology Solutions is seeking a Quality Engineer to support the site’s quality validation, product qualification, and risk management programs in a regulated environment.

You will collaborate with cross-functional teams across Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to ensure product safety and regulatory compliance throughout the validation lifecycle.