Quality Assurance Engineer (Medical Devices)

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

Annual salary: $82,400–$90,000, plus eligibility for an annual bonus.

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 investigations into manufacturing and operational quality issues, including data gathering, documentation, and follow-up actions.
• Analyze quality data to identify trends, recurring issues, and opportunities for process and product improvement.
• Support nonconforming material investigations and Material Review Board activities, including documentation and disposition coordination.
• Assist with process validation, equipment qualification, quality assessments, internal audits, and inspection readiness.
• Support supplier quality investigations and corrective action activities.
• Partner with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams to resolve site quality issues and maintain 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, quality operations, or a related role.
• Experience or early-career exposure to medical devices, manufacturing, or another regulated industry.
• Understanding of engineering principles, data analysis, root cause investigation, and structured problem-solving methods.
• Familiarity with FDA Quality System requirements, ISO 13485, nonconformance management, MRB processes, process validation, or equipment qualification.
• Advanced English is required. The role requires regular presence at a manufacturing or operational facility in Chelmsford, Massachusetts, and does not provide immigration sponsorship.

Nice to have

• Experience supporting supplier quality investigations or corrective action activities.
• Experience using quality system or data analysis tools.

Culture & Benefits

• Work in a medical technology environment focused on improving patient outcomes.
• Collaborate across manufacturing, operations, engineering, supplier quality, and regulatory functions.
• Hybrid or on-site work with occasional travel for training, audits, investigations, or multi-site support.
• Annual bonus eligibility and comprehensive benefits.
• Work with a company operating in more than 140 countries.

Hiring process

• Applications are accepted on an ongoing basis until the position is filled.