Quality Assurance Compliance Specialist I

About the Role

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.

Key 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.

Requirements & Tech Stack

• 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).
• 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).

Qualifications

• 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.
• 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.

Physical Demands

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

On-site requirements: Applicants are expected to reside within a reasonable commuting distance of Chelmsford, MA. This role does not offer relocation.

ZOLL does not provide immigration-related sponsorship for this role.