Apply on Employer Site

New Horizon Medical Solutions · 1 day ago

Quality Manager

Las Vegas, NV

Full-time

Onsite

Entry, Mid Level

$75K/yr - $110K/yr

2+ years exp

New Horizon Medical Solutions is a rapidly expanding healthcare technology company specializing in biologics and advanced wound care solutions. The Quality Manager is responsible for leading and improving the Quality Management System to ensure compliance with regulatory and industry standards while managing quality processes and developing staff.

BillingMedicalMedical Device

Responsibilities

Lead and continuously improve QMS programs, including but not limited to deviations, nonconformances, complaints, CAPA, change control, risk management, validation, supplier/material qualification, and product release

Ensure quality events, investigations, CAPAs, change controls, protocols, and reports are completed accurately, on time, and with effective risk mitigation

Conduct and support root-cause analyses, risk assessments, and impact assessments for Quality Events

Ensure SOPs and internal procedures are current, accurate, and updated as required

Track, analyze, and report Quality metrics/KPIs to demonstrate system effectiveness

Lead internal and external audits and manage audit responses

Mentor staff and building a robust Quality Culture

Maintain controlled document management, storage, archival, and issuance

Lead continuous improvement initiatives using Lean/Six Sigma principles

Conduct QA and regulatory research

Collaborate cross-functionally on supplier qualification and change notifications

Support departmental budget management

Qualification

Quality Management System (QMS)GxP/ISO 13485 experienceCAPA managementLean/Six Sigma principlesCTBSASQ CertificationProblem-solving skillsCommunication skillsLeadership skills