Description

Job Description

Sarnova is seeking a dedicated and detail-oriented Quality Specialist to support our Quality Management System (QMS) and ensure ongoing compliance with FDA regulations and ISO standards. This role will be responsible for critical activities that support inspection readiness, regulatory compliance, and continuous improvement across our operations. The Quality Specialist will work cross functionally with multiple teams to maintain and enhance quality processes essential to patient safety and regulatory success.

Hybrid Schedule: M-th in office, Fri work from home

Sarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management.

Summary:

Sarnova is seeking a dedicated and detail-oriented Quality Specialist to support our Quality Management System (QMS) and ensure ongoing compliance with FDA regulations and ISO standards. This role will be responsible for critical activities that support inspection readiness, regulatory compliance, and continuous improvement across our operations. The Quality Specialist will work cross functionally with multiple teams to maintain and enhance quality processes essential to patient safety and regulatory success.

Essential Duties and 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.

Skills/Experience 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.
• Proficiency in Spanish is a plus.

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients' lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.

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