Sr. Manager of Quality Assurance

ZOLL Medical
Pittsburgh
Workplace: OnsiteFull timeUSD 140,000 - 180,000 annuallyFunction: QA, Test & Release EngineeringExperience: 7+ yearsEducation: bachelorsSkills: ["Leadership","Problem-solving","Communication","Organizational skills","Data-driven decision-making"]

Lead Quality Assurance for a Class 3 PMA medical device manufacturing organization, ensuring ongoing QMS compliance, effectiveness, and continuous improvement. Oversee day-to-day QA operations, manage Quality Engineering and Inspection teams, and ensure product and process adherence to strict domestic and international regulatory standards including FDA, QSR, ISO 13485/14971, MDR, and ATF. Manage inspections and product release, analyze quality metrics, and drive risk management, CAPA, change control, and PLM processes.

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ZOLL Medical
ZOLL Medical
3 days ago

Sr. Manager of Quality Assurance

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Last checked: 3 hours agoStatus: Live

Job Summary

Lead Quality Assurance for a Class 3 PMA medical device manufacturing organization, ensuring ongoing QMS compliance, effectiveness, and continuous improvement. Oversee day-to-day QA operations, manage Quality Engineering and Inspection teams, and ensure product and process adherence to strict domestic and international regulatory standards including FDA, QSR, ISO 13485/14971, MDR, and ATF. Manage inspections and product release, analyze quality metrics, and drive risk management, CAPA, change control, and PLM processes.
Location: Pittsburgh
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Sr. Manager level

Key Responsibilities

  • •Manage and maintain inspection and product release programs for incoming/in-process materials and finished goods.
  • •Collect data and analyze quality metrics, monitoring QA processes and meeting production and department schedules including audits and calibration.
  • •Liaise with external inspectors and auditors to support compliance and inspection readiness.
  • •Manage Quality Engineering and Inspection departments, serving as an escalation point for complex quality issues and driving process adherence.
  • •Create and maintain written inspection instructions, perform trend analysis, and support company-wide strategy for CAPA, risk management, change control, and PLM.

Pay and Benefits

Salary: USD 140,000 - 180,000 annually

Key Requirements

  • •Bachelor's degree required; Master's Degree in Engineering or MBA preferred.
  • •Minimum of 7 years of management/leadership experience required.
  • •At least 4 years of experience as a quality assurance engineer or in a technical discipline in medical device manufacturing (preferred).
  • •ASQ certifications (CQE, CRE, or CQM) and Lean Six Sigma preferred.
  • •In-depth knowledge of 21 CFR 820, ISO 13485, MDR, and ISO 14971, with experience applying Lean Six Sigma methods.
Experience:7+ yearsMedical device manufacturingQuality assuranceRegulated environments
Education:Bachelor's
Skills:LeadershipProblem-solvingCommunicationOrganizational skillsData-driven decision-making
Certifications:ASQ Certified CQEASQ Certified CREASQ Certified CQMLean Six Sigma
Tech Stack:Quality Management System (QMS)21 CFR 820ISO 13485ISO 14971European Medical Device Regulation (MDR)CAPAChange controlPLMFDA QSRATFLean Six SigmaDMAICGage R&RDesign of ExperimentsProcess Capability

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