Quality Assurance Engineer (Medical Devices)

Location: Hybrid in Chelmsford, Massachusetts, United States; 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.

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, recurring issues, and quality-improvement opportunities.
• Support CAPA and nonconformance activities, including documentation, tracking, and follow-up.
• Participate in design reviews, quality assessments, and design verification and validation quality activities.
• Collaborate 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.
• 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 is required.

Nice to have

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

Culture & Benefits

• Hybrid work with occasional travel as needed for team meetings, training, investigations, audits, or site support.
• Work focuses on improving patient outcomes, product reliability, patient safety, and regulatory compliance.
• Culture values innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans are available.
• Applications remain open until the position is filled.