Sarnova
Sarnova, a leading national specialty distributor in Emergency Medical Services (EMS) and Respiratory Markets, 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. The role will support inspection readiness, regulatory compliance, and continuous improvement across our operations.
Hybrid Schedule: Monday through Thursday in office, Friday work from home.
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 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.
Qualifications
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.
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Hybrid Schedule: Monday through Thursday in office, Friday work from home.
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 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.
Qualifications
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.
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