Quality Assurance Compliance Specialist I (Medical Devices)

Location: Chelmsford, Massachusetts, United States

Salary: $60,000–$70,000 per year

Company

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

What you will do

• Support the Quality Management System in compliance with FDA 21 CFR Part 820, ISO 13485, EUMDR, and global regulatory requirements.
• Assist with CAPA initiation, investigation support, tracking, and effectiveness verification.
• Participate in internal audits and support FDA, Notified Body, and MDSAP inspections and readiness activities.
• Track, investigate, and close audit nonconformities while maintaining quality documentation under Good Documentation Practices.
• Support UDI data generation, verification, and maintenance in systems such as GUDID and EUDAMED.
• Track training requirements and support product compliance and regulatory documentation activities.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field preferred; an associate degree or technical certification with relevant experience may be considered.
• 0–2 years of experience in a regulated industry, preferably medical devices, pharmaceuticals, or biotechnology.
• Familiarity with FDA QSR, ISO 13485, MDR, MDSAP, CAPA, audits, nonconformance management, and Good Documentation Practices.
• Strong attention to detail, data integrity, communication, organization, and prioritization skills.
• Ability to work cross-functionally in a regulated environment.
• Experience with UDI systems, product regulatory compliance processes, or electronic Quality Management Systems is preferred.

Culture & Benefits

• Work with products and software intended to improve patient outcomes and save lives.
• Collaborate within a fast-growing organization operating in more than 140 countries.
• Culture emphasizes innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans are available.