Quality Assurance Compliance Engineer (Medical Devices)

Location: Chelmsford, Massachusetts, United States

Annual salary: $90,000–$110,000

Company

hirify.global develops medical devices, software, and related services for serious cardiopulmonary and respiratory conditions.

What you will do

• Review CAPA content, monitor CAPA KPIs, and lead cross-functional CAPA teams.
• Maintain and continuously improve CAPA processes and compliance with applicable regulations.
• Support internal audit planning, scheduling, finding responses, and timely closure.
• Participate in external audits related to the manufacturing site and support quality-system compliance.
• Review quality-system documents, health risk assessments, and regulatory communications.
• Help define QMS training requirements and support training for employees.

Requirements

• Four-year degree.
• At least 5 years of related experience in a regulated environment, preferably medical devices.
• Experience with FDA QSR, ISO 13485, MDD, MDR, MDSAP, and ISO 14971.
• Proficiency in auditing techniques, project management, time management, and professional communication.

Culture & Benefits

• Work focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Innovation, self-motivation, and an entrepreneurial spirit are valued.
• Comprehensive employee benefits are available.
• ZOLL operates in more than 140 countries.