Quality Assurance Compliance Specialist I

ZOLL Medical Corporation•Chelmsford, MA

22h•$60,000 - $70,000

About The Position

The Quality Assurance Compliance Specialist I supports the Quality Assurance Compliance team in maintaining compliance with global regulatory requirements and the Quality Management System (QMS). This role assists with CAPA activities, audit programs, quality system documentation, and regulatory compliance initiatives while developing foundational knowledge of medical device quality systems and regulations.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred
Associate degree or technical certification with relevant experience may be considered
0–2 years of experience in a regulated industry (medical device, pharmaceutical, or biotech preferred)
Internship, co-op, or academic exposure to quality systems strongly preferred
Familiarity with global medical device regulations (FDA QSR, ISO 13485, MDR, and/or MDSAP)
Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP) preferred
Strong attention to detail and data integrity mindset
Effective written, verbal, and interpersonal communication skills
Strong organizational, time management, and prioritization abilities
Ability to work cross-functionally in a regulated environment
Foundational understanding of FDA 21 CFR Part 820, ISO 13485, and quality system principles, preferred
Experience with UDI systems and product regulatory compliance processes, preferred
Experience with electronic Quality Management Systems (eQMS), preferred

Responsibilities

Support maintenance of the Quality Management System (QMS) in compliance with FDA (21 CFR Part 820), ISO 13485, EUMDR, and global regulatory requirements
Assist with CAPA processes, including initiation, investigation support, tracking, and effectiveness verification
Participate in internal audits and support external inspections (FDA, Notified Bodies, MDSAP) including audit readiness activities
Assist with tracking, investigation, and closure of audit nonconformities
Maintain quality documentation in accordance with Good Documentation Practices (GDP)
Support regulatory compliance activities including: UDI data generation, verification, and maintenance (e.g., GUDID, EUDAMED), Product compliance and regulatory documentation support
Assist with the training program by tracking training requirements and ensuring QMS compliance