Quality Engineer: NPI Quality & Compliance Lead Devens

Watson-Marlow México; Massachusetts; Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Retirement plan

Parental leave

Fertility benefits

Generous time off

Volunteer days

Healthcare plans

Job summary

Watson-Marlow Fluid Technology Solutions is seeking a Quality Engineer for the Deven, MA site to support the development and maintenance of quality validation, product qualification, and risk management programs.

This role collaborates with Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to drive CAPA, V&V, audits, and continuous improvement across the NPI lifecycle.

The position offers a salary range of USD 85,000 to 105,000 with a comprehensive benefits package.

Qualifications

• Bachelor's degree in engineering or a scientific discipline required.
• Minimum of 2-3 years’ experience in Quality Assurance within a regulated industry.
• Proven working knowledge of ISO 13485 and ISO 9001 standards.
• Strong ability to engage and communicate effectively with cross-functional stakeholders.
• Demonstrated expertise in product and process validation methodologies.
• In-depth understanding of the design and development lifecycle.
• Proficient in conducting internal audits; lead auditor certification is highly desirable.
• Established track record in driving continuous improvement initiatives and applying lean methodologies.
• Advanced problem-solving capabilities, including root cause analysis and CAPA management.
• Excellent communication, planning, and organizational skills.

Responsibilities

• Develop, implement, and sustain effective quality management system (QMS) processes, including procedures and records.
• Provide quality engineering guidance for New Product Introduction (NPI) projects and change management.
• Collaborate with validation SMEs to ensure effective V&V of new products and processes.
• Lead investigations of nonconformities using eQMS Quality Event process.
• Drive corrective and preventive actions (CAPA) through root cause analysis.
• Drive improvements in design, product, and process changes with risk assessment and documentation.
• Collaborate with cross-functional teams to implement quality improvements aligned with the WMFTS Quality Strategy.
• Support validation activities by developing and maintaining validation protocols and documentation.
• Participate in internal audits and generate audit reports to drive improvements.
• Provide training and guidance on quality tools and best practices.

Skills

Quality Assurance

Regulated industry

Risk management

Education

Bachelor's degree in engineering or science

Tools

eQMS

Job description

Watson-Marlow Fluid Technology Solutions is seeking a Quality Engineer for the Deven, MA site to support the development and maintenance of quality validation, product qualification, and risk management programs.

This role collaborates with Engineering, Manufacturing, R&D, Supply Chain, and Quality Assurance to drive CAPA, V&V, audits, and continuous improvement across the NPI lifecycle.

The position offers a salary range of USD 85,000 to 105,000 with a comprehensive benefits package.