Quality Assurance Engineer (Medical Devices)

Location: Chelmsford, Massachusetts, United States; hybrid/remote with occasional travel for team meetings, training, investigations, audits, or site support.

Annual salary: $85,000–$100,000, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for 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.
• Maintain product risk-management files, perform risk assessments, and support compliance with applicable standards and procedures.
• Analyze complaint, service, and field-performance data to identify trends, recurring issues, 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 quality activities.
• Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/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.
• Internship, co-op, or early-career experience in medical devices, manufacturing, or a regulated industry.
• Basic understanding of engineering principles, data analysis, and problem-solving techniques.
• Strong organization, attention to detail, documentation, written and verbal communication, and cross-functional collaboration skills.
• Ability to work effectively in a remote environment while collaborating across teams and time zones.
• 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 proficiency.

Nice to have

• Experience with quality-system tools or data-analysis tools.
• Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971.

Culture & Benefits

• Purpose-driven work focused on improving patient outcomes and saving lives.
• Innovation, self-motivation, and an entrepreneurial spirit are valued.
• Hybrid/remote work arrangement with occasional travel as needed.
• Annual bonus eligibility and comprehensive benefits.
• Applications remain open until the position is filled.