Hiring: Quality Assurance Compliance Specialist I Company: ZOLL Medical Corporation Location: Chelmsford, MA Job Posted Time: 2026-09-10 14:43:47 Employment Type: Internship Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job Experience: •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 Required Skills: •Due to the on‑site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Chelmsford, MA). This role does not offer relocation. •ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future. •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) •UDI data generation, verification, and maintenance (e.g., GUDID, EUDAMED) Qualifications: •Operational familiarity with global medical device regulations (FDA QSR, ISO 13485, MDR, and/or MDSAP) •Operational 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 •Demonstrated capacity to work cross-functionally in a regulated environment •Foundational understanding of FDA 21 CFR Part 820, ISO 13485, and quality system principles, preferred •Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred •Associate degree or technical certification with relevant experience may be considered Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!