Product Quality Assurance Engineer (Medical Devices)

Location: Hybrid in Chelmsford, MA; applicants must live within a reasonable commuting distance. No relocation is offered.

Salary: $82,400–$90,000 annual salary.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, serving EMS, hospital, public safety, and military customers worldwide.

What you will do

• Support product and complaint investigations through data gathering, product failure analysis, and root-cause analysis activities.
• Support product risk management, including risk assessments, documentation updates, and maintenance of risk-management files.
• Analyze complaint, service, and field-performance data to identify trends and product quality improvement opportunities.
• Support CAPA and nonconformance activities, including documentation, tracking, and follow-up actions.
• Participate in design reviews, quality assessments, and design verification and validation activities.
• Collaborate with Engineering, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams.

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, or risk-management processes.
• Exposure to medical-device design controls, verification and validation, or post-market quality activities.
• Advanced English is required; U.S. work authorization is required, and hirify.global does not provide immigration-related sponsorship.

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

• Occasional travel may be required for team meetings, training, investigations, audits, or site support.
• Work includes collaboration across teams and time zones, with the ability to work effectively in a remote environment when appropriate.
• Culture emphasizes innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits are available.