Sarnova · 2 days ago
Quality Specialist - Sarnova
Dublin, OH
Full-time
Hybrid
Senior Level
5+ years expSarnova is a leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets. The Quality Specialist will support the Quality Management System (QMS), ensuring compliance with FDA regulations and ISO standards while working cross-functionally to enhance quality processes essential to patient safety.
Health CareHealth DiagnosticsMedical Device
Responsibilities
Support compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards
Manage product identification and labeling compliance, including GTIN assignment, system audit and verification
Administer document control processes to ensure accuracy, version control, and timely approvals
Process and track complaints in accordance with regulatory requirements and internal procedures
Perform vendor surveillance activities, including qualification and ongoing monitoring of suppliers
Provide recall support through documentation, tracking, and cross-functional coordination
Upload and maintain controlled documentation in our ERP and other relevant systems
Administer and track training programs, ensuring compliance with QMS and regulatory requirements
Support change control activities, including risk assessment and documentation of product and process changes
Partner cross-functionally with Quality, Regulatory, Operations, and other stakeholders to ensure alignment and compliance
Assist in preparation and support for FDA inspections, ISO audits, and internal audits
Qualification
Required
Bachelor's degree in a scientific, technical, or related discipline
5+ years of experience in a quality role within the medical device industry
Strong working knowledge of FDA 21 CFR 820, ISO 13485, and GUDID requirements
Experience in document control and complaint handling processes
Proficiency with Microsoft Word, Excel, SharePoint, and DocuSign
Strong organizational skills with keen attention to detail and ability to manage multiple priorities
Effective verbal and written communication skills
Preferred
Proficiency in Spanish is a plus
Benefits
401(k) Plan
Company
Sarnova
Sarnova Inc., through its subsidiaries, provides healthcare products and distributes emergency medical equipment and supplies.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$10.5M2018-03-12Acquired
2009-12-31Series Unknown· $0.5M
2009-04-24Series Unknown· $10M
Leadership Team
Brian Ellis
Chief Operating Officer
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