Quality Assurance Compliance Specialist I

ZOLL Medical
United States
Workplace: OnsiteFull timeUSD 60,000 - 70,000 annuallyFunction: QA, Test & Release Engineering0Skills: ["Attention to detail","Data integrity mindset","Written communication","Verbal communication","Organizational skills"]

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.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
ZOLL Medical
ZOLL Medical
1 month 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: 26 days 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
WebsiteLinkedIn