Quality Assurance Engineer (Medical Devices)

Location: Hybrid role based in Chelmsford, Massachusetts, with regular onsite presence at a manufacturing or operational facility. Applicants must live within a reasonable commuting distance; relocation is not offered.

Salary: $82,400–$90,000 annually, plus eligibility for an annual bonus.

Company

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

What you will do

• Support investigations into manufacturing and operational quality issues, including data collection, documentation, follow-up actions, and root cause analysis.
• Analyze manufacturing quality data to identify trends, recurring issues, and process or product improvement opportunities.
• Assist with nonconforming material investigations and Material Review Board activities.
• Support process validation, equipment qualification, quality assessments, audits, and inspection readiness.
• Contribute to manufacturing process improvement, supplier corrective actions, and continuous improvement initiatives.
• Collaborate with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams while maintaining accurate quality records.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• At least 2 years of relevant experience in quality engineering, manufacturing engineering, or a related quality or operations role; regulated-industry experience is preferred.
• Understanding of engineering principles, data analysis, structured problem-solving, and root cause investigation tools.
• Familiarity with FDA Quality System requirements, ISO 13485, medical device regulations, nonconformance management, process validation, or equipment qualification.
• Advanced English proficiency is required.
• Applicants must be authorized to work in the United States without current or future immigration sponsorship.

Nice to have

• Internship, co-op, or early-career experience in medical devices, manufacturing, or another regulated industry.
• Experience with supplier quality investigations or corrective action activities.
• Experience using quality system or data analysis tools.

Culture & Benefits

• Hybrid or onsite work with occasional travel for training, audits, investigations, or multi-site support.
• Annual bonus eligibility and comprehensive benefits.
• Work focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Environment emphasizing innovation, self-motivation, and an entrepreneurial spirit.