Quality Assurance Compliance Specialist I (Medtech)

TL;DR

Quality Assurance Compliance Specialist I (Medtech): Maintaining compliance with global regulatory requirements and the Quality Management System (QMS) with an accent on CAPA activities and audit programs. Focus on ensuring adherence to FDA and ISO 13485 standards, managing nonconformities, and supporting regulatory documentation.

Location: Onsite in Chelmsford, MA

Salary: $60,000 - $70,000

Company

hirify.global develops innovative lifesaving medical devices and software solutions for cardiopulmonary and respiratory conditions worldwide.

What you will do

• Support the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and EUMDR.
• Assist with CAPA processes, including initiation, investigation support, tracking, and effectiveness verification.
• Participate in internal audits and support external inspections from FDA, Notified Bodies, and MDSAP.
• Maintain quality documentation in accordance with Good Documentation Practices (GDP) and handle audit nonconformities.
• Manage UDI data generation and verification for systems like GUDID and EUDAMED.
• Track training requirements to ensure ongoing QMS compliance.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field (preferred).
• 0–2 years of experience in a regulated industry such as medical devices, pharmaceuticals, or biotech.
• Familiarity with global regulations including FDA QSR, ISO 13485, MDR, and/or MDSAP.
• Knowledge of CAPA, audits, nonconformance management, and Good Documentation Practices (GDP).
• Ability to work onsite in Chelmsford, MA.

Culture & Benefits

• Mission-driven environment focused on improving patient outcomes and saving lives.
• Culture that values innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans.
• Opportunity to build a career within a fast-growing global company operating in over 140 countries.