Quality Assurance Quality Control Manager

ZOLL Medical
United States
Workplace: OnsiteFull timeUSD 100,000 - 120,000 annuallyFunction: QA, Test & Release EngineeringExperience: 4-6 yearsEducation: bachelorsSkills: ["Problem-solving","Communication","Leadership"]

Lead and manage the quality assurance and quality control program for acute care electrode production. Oversee inspection, CAPA, training, audits, and continuous improvement in a regulated medical device environment; ensure GMP, ISO, and FDA QMSR compliance; mentor cross-functional teams and drive quality metrics and policy implementation across production and QA operations.

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ZOLL Medical
ZOLL Medical
6 months ago

Quality Assurance Quality Control Manager

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Source: Company careers pageValidated by: Fursa AI
Last checked: 13 days agoStatus: Live

Job Summary

Lead and manage the quality assurance and quality control program for acute care electrode production. Oversee inspection, CAPA, training, audits, and continuous improvement in a regulated medical device environment; ensure GMP, ISO, and FDA QMSR compliance; mentor cross-functional teams and drive quality metrics and policy implementation across production and QA operations.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Manager level

Key Responsibilities

  • •Manage and provide guidance to personnel engaged in final and incoming inspection and testing activities.
  • •Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection.
  • •Create, document and implement inspection criteria and procedures.
  • •Provide and oversee inspection activity for product throughout production cycle.
  • •Collect, analyze and disseminate quality data throughout the organization.
Travel: Low travel

Pay and Benefits

Salary: USD 100,000 - 120,000 annually
Perks:Health Insurance401kAnnual Bonus

Key Requirements

  • •Four-year degree in a technical or science discipline
  • •4-6 years experience in a regulated environment (preferably medical device)
  • •1-3 years experience in supervisory/management role
  • •Strong problem solving and analytical skills; effective written and verbal communication
  • •Experience with ISO 13485 and FDA QMSR is preferred
Experience:4-6 yearsMedical devicesQuality assuranceManufacturing operations
Education:Bachelor's
Skills:Problem-solvingCommunicationLeadership
Languages:English
Tech Stack:ISO 13485FDA QMSRGMPCAPACalibration

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