Quality Specialist, Private Label and Kitting

Overview The Quality Specialist will be responsible for assisting with the Company's compliance with all laws and regulation and managing risk relating to its private label products and kitting business. Hybrid Schedule: M&F home office based, T-TH in office 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. Responsibilities Summary: The Quality Specialist will be responsible for assisting with the Company's compliance with all laws and regulation and managing risk relating to its private label products and kitting business. Organizational Impact: As a Quality Specialist at Sarnova, you will be instrumental in ensuring our organization's compliance with applicable laws, regulations, and industry standards. Your expertise will not only ensure adherence to regulatory standards but also enhance our reputation as a trustworthy and compliant organization in the eyes of regulators, stakeholders, and customers alike. Essential Duties and Responsibilities: Assist in conducting due diligence and audits of both new and existing private-label product manufacturers, as well as manufacturers of company-owned products, to verify quality standards and regulatory compliance Review labels for Company's private label products and kits to ensure labels contain the appropriate UDI, instructions for use, contraindications and other required information Review and provide guidance on marketing materials associated with product sales Manage the timely investigation and resolution of private label and kitting product complaints to ensure compliance with quality standards and regulatory requirements Identify trending quality issues reported by customers, account managers and warehouse operations related to private label and kitting products Achieve corporate quality goals and monitor key performance indicators (KPIs) to uphold excellence in the company's private-label products and kitting operations. Develop and manage the implementation of and reports on the progress of special projects as assigned Support Company audits and collaborate with operations to develop and implement process improvements to address gaps identified in audit findings and regulatory changes Perform additional job duties as assigned Skills/Experience Required: Education: Bachelor's degree required 3 to 5 years of quality or regulatory experience in the medical device or pharmaceutical industry Direct experience in the medical device or pharmaceutical industry desired Demonstrated familiarity with FDA and state regulations and the application of sound Quality Systems to ensure compliance Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies Strong written and verbal communication skills Well-developed organizational and cross functional skills Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software 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.Summary: The Quality Specialist will be responsible for assisting with the Company's compliance with all laws and regulation and managing risk relating to its private label products and kitting business. Organizational Impact: As a Quality Specialist at Sarnova, you will be instrumental in ensuring our organization's compliance with applicable laws, regulations, and industry standards. Your expertise will not only ensure adherence to regulatory standards but also enhance our reputation as a trustworthy and compliant organization in the eyes of regulators, stakeholders, and customers alike. Essential Duties and Responsibilities: Assist in conducting due diligence and audits of both new and existing private-label product manufacturers, as well as manufacturers of company-owned products, to verify quality standards and regulatory compliance Review labels for Company's private label products and kits to ensure labels contain the appropriate UDI, instructions for use, contraindications and other required information Review and provide guidance on marketing materials associated with product sales Manage the timely investigation and resolution of private label and kitting product complaints to ensure compliance with quality standards and regulatory requirements Identify trending quality issues reported by customers, account managers and warehouse operations related to private label and kitting products Achieve corporate quality goals and monitor key performance indicators (KPIs) to uphold excellence in the company's private-label products and kitting operations. Develop and manage the implementation of and reports on the progress of special projects as assigned Support Company audits and collaborate with operations to develop and implement process improvements to address gaps identified in audit findings and regulatory changes Perform additional job duties as assigned Skills/Experience Required: Education: Bachelor's degree required 3 to 5 years of quality or regulatory experience in the medical device or pharmaceutical industry Direct experience in the medical device or pharmaceutical industry desired Demonstrated familiarity with FDA and state regulations and the application of sound Quality Systems to ensure compliance Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies Strong written and verbal communication skills Well-developed organizational and cross functional skills Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software 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.