The Manager, Quality Assurance is a key member of the Compliance, Regulatory Affairs, and Quality team and is responsible for leading and improving the Quality Management System (QMS) to ensure compliance with regulatory and industry standards. This role provides day-to-day management of quality processes, develop staff, and proactively identifies and resolves quality issues for HCT/Ps and Medical Devices.

Required expertise: Quality system leadership in a regulated or healthcare environment, including experience with 21 CFR 1271, 21 CFR 820, ISO 13485, AATB Standards, GxP, and strong problem-solving, communication, and leadership skills.

Primary Responsibilities (85–90%)

• 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.

Secondary Responsibilities (10–15%)

• 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.

Requirements

• Bachelor’s degree or equivalent experience
• 2+ years’ experience in a GxP/ISO 13485/regulated or healthcare environment and 1+ year in QA/QMS role.
• Preferred: CTBS and or ASQ Certification

About New Horizon Medical Solutions

Located in sunny Las Vegas, NV, New Horizon Medical Solutions is a distributor of a diversified portfolio of wound care products including HCT/Ps and medical devices.

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