ZOLL Medical

3 days ago

Quality Assurance Compliance Specialist I

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Support the Quality Assurance Compliance team in maintaining compliance with global regulatory requirements and the Quality Management System (QMS) for medical devices. Assist with CAPA activities, audit programs, quality documentation, and regulatory compliance initiatives, including UDI data maintenance and training tracking. Participate in internal audits and support external inspections from FDA, Notified Bodies, and MDSAP, including audit readiness and nonconformity closure.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Entry level

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) and support regulatory compliance activities including UDI data maintenance and training program tracking.

Pay and Benefits

Salary: USD 60,000 - 70,000 annually

Key Requirements

•Bachelor’s degree in Engineering or Life Sciences (preferred) or an associate degree/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 including FDA QSR, ISO 13485, MDR, and/or MDSAP.
•Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP).

Experience:0Medical devicePharmaceuticalBiotechRegulated industry

Education:

Skills:Attention to detailData integrity mindsetWritten communicationVerbal communicationOrganizational skills

Tech Stack:FDA 21 CFR Part 820ISO 13485EUMDRQMSCAPAAudit readinessGDPUDIGUDIDEUDAMEDMDRMDSAPNotified BodiesEQMS

Company Brief

ZOLL Medical

Designs and manufactures medical devices and software for critical care and rescue, including defibrillators, ventilators, CPR feedback systems, and monitoring solutions for hospitals, emergency responders, and public access settings.

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn

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ZOLL Medical

3 days ago

Quality Assurance Compliance Specialist I

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 6 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Entry level

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) and support regulatory compliance activities including UDI data maintenance and training program tracking.

Pay and Benefits

Salary: USD 60,000 - 70,000 annually

Key Requirements

•Bachelor’s degree in Engineering or Life Sciences (preferred) or an associate degree/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 including FDA QSR, ISO 13485, MDR, and/or MDSAP.
•Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP).

Experience:0Medical devicePharmaceuticalBiotechRegulated industry

Education:

Skills:Attention to detailData integrity mindsetWritten communicationVerbal communicationOrganizational skills

Tech Stack:FDA 21 CFR Part 820ISO 13485EUMDRQMSCAPAAudit readinessGDPUDIGUDIDEUDAMEDMDRMDSAPNotified BodiesEQMS

Company Brief

ZOLL Medical

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn