Product Quality Assurance Engineer (Medical Devices)

Location: Hybrid in Chelmsford, Massachusetts; applicants must reside within a reasonable commuting distance. The role does not offer relocation.

Annual salary: $82,400–$90,000

Company

hirify.global develops medical devices, software, and related services for cardiopulmonary and respiratory care, serving EMS, hospitals, public safety, and military customers.

What you will do

• Support product and complaint investigations through data gathering, failure analysis, and root cause analysis activities.
• Maintain product risk management documentation, perform risk assessments, and support risk management files.
• Analyze complaint, service, and field performance data to identify trends and product quality improvements.
• Support CAPA and nonconformance activities, including documentation, tracking, and follow-up.
• Participate in design reviews, quality assessments, and design verification and validation activities.
• Collaborate with engineering, manufacturing, supplier quality, regulatory, clinical, and post-market teams while maintaining accurate quality records.

Requirements

• Bachelor’s degree in engineering or a related technical discipline.
• At least 2 years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
• Knowledge of engineering principles, data analysis, problem-solving, documentation, and established quality processes.
• Familiarity with complaint handling, CAPA, nonconformance systems, risk management, or medical-device design controls.
• Advanced English proficiency required.
• Immigration-related sponsorship is not available; applicants must not require ZOLL sponsorship now or in the future.

Nice to have

• Internship, co-op, or early-career experience in medical devices, manufacturing, or another regulated industry.
• Experience with quality-system or data-analysis tools.
• Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971.

Culture & Benefits

• Hybrid work with occasional travel for team meetings, training, investigations, audits, or site support.
• Collaboration across engineering, manufacturing, regulatory, clinical, and post-market functions.
• Work focused on patient safety, product reliability, regulatory compliance, and improving outcomes for patients with critical cardiopulmonary conditions.
• Employment with a company operating in more than 140 countries.