Quality Management System (QMS) Engineer jobs in United States
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DENTALEZ ยท 3 weeks ago

Quality Management System (QMS) Engineer

DentalEZ is seeking a proactive QMS Engineer to help strengthen and maintain their Quality Management System in a regulated manufacturing environment. This role involves improving systems, partnering across teams, and making a visible impact on compliance and continuous improvement.

Health CareMedicalMedical Device
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Responsibilities

Own and maintain QMS processes including document control, NCMRs, complaints, calibration, and incoming inspection
Manage creation, review, approval, and training of quality documents
Lead or support internal QMS audits and corrective/preventive actions (CAPAs)
Investigate quality issues and customer complaints using root cause analysis
Track and report quality KPIs to drive continuous improvement
Partner with Quality, Regulatory, Engineering, Manufacturing, and Supply Chain teams
Support regulatory and RA/QA administrative initiatives as needed

Qualification

Quality Management SystemISO standardsRoot cause analysisPrecision measurement toolsProblem-solving skillsOrganizational skillsCommunication skills

Required

Bachelor's degree from an accredited university
3+ years of quality experience in a manufacturing environment
Experience interpreting engineering drawings and using precision measurement tools
Strong problem-solving, organization, and communication skills
Authorized to work in the U.S. without sponsorship

Preferred

Working knowledge of ISO standards (ISO 13485, AS9100, ISO 9001 preferred)

Company

DENTALEZ

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DentalEZ is a medical devices company specialising in surgery devices and equipment.