Product Quality Assurance Engineer (Medtech)

TL;DR

Product Quality Assurance Engineer (Medtech): Supporting product quality throughout the lifecycle with an accent on complaint investigations, risk management, and performance monitoring. Focus on collaborating with cross-functional teams to ensure compliance with medical device standards and improving patient safety.

Location: Must reside within a reasonable commuting distance of Chelmsford, MA. This is a hybrid role and does not offer relocation.

Salary: $82,400 – $90,000

Company

A global leader in medical devices and software solutions dedicated to improving patient outcomes for cardiopulmonary and respiratory conditions.

What you will do

• Assist with product and complaint investigations, including root cause analysis.
• Support risk management activities and maintain risk management files.
• Analyze field performance data to identify trends and quality improvement opportunities.
• Manage CAPA and nonconformance documentation and follow-up actions.
• Participate in design reviews and quality assessments throughout the product lifecycle.
• Collaborate with R&D, Manufacturing, and Regulatory teams to resolve quality issues.

Requirements

• Bachelor's Degree in Engineering or a related technical discipline.
• 2+ years of experience in quality or product engineering, preferably in a regulated industry.
• Must be authorized to work in the US; no immigration sponsorship provided.
• Must reside within a reasonable commuting distance of Chelmsford, MA.
• Strong organizational skills and attention to detail.
• Ability to work effectively in a cross-functional team environment.

Nice to have

• Experience with FDA Quality System requirements, ISO 13485, or ISO 14971.
• Familiarity with complaint handling and CAPA systems.
• Experience using quality system or data analysis tools.

Culture & Benefits

• Comprehensive benefits plans including health and wellness options.
• Opportunity to work on lifesaving medical technology.
• Collaborative environment valuing innovation and entrepreneurial spirit.
• Commitment to professional growth and career development.