Quality Assurance Associate

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as QuidelOrtho, we are seeking a Quality Assurance Associate to perform Quality Assurance activities, such as maintain and improve the Quality System, conduct internal and external audits, technosurveillance activities such as execute field action notifications, recalls, complaints and submission of reports to local Health Authority, if applicable.

Responsibilities

• Prepare and submit periodic Technosurveillance reports to the local Health Authority.

• Maintain and improve the Quality Management System (QMS). Support other QMS activities, such as internal/external audits and Quality trainings.

• Execute Field Action Notifications and Recall activities, as well as, reporting them to the local Health Authority, when applicable.

• Provide Quality Support to the Sanitary Responsible and Technosurvillance Responsible.

• Support the Local Authority Inspections.

• Supplier Qualification and follow-up.

• Provide Quality information and support to Supply Chain, International Trade, Marketing and Sales department.

• Provide Quality documents and information when requested by the customers.

• Provide material safety data sheets to Sales Representatives for customers.

• Provide origin CoAs for customers, when required.

• Support to third parties with Quality information.

• Support Warehouse quality assurance operation, as needed.

• Perform other work related duties as assigned.

The Individual

• Major in Pharmacy, Chemistry or Biochemistry, with at least 3 years of experience in Quality and/or Technosurveillance.

• Certified as Internal Auditor.

• Certified as External Auditor ISO 9000.

• At least 3 years of experiencie in IVD (In Vitro Diagnostics), or Medical devices industry in Quality Assurance and advanced knowledge in quality regulations.

• Advanced user in Microsoft Office and internet and knowledge in SAP system QA/SC transactions.

• Auditing process.

• English: Intermediate Level

• 3PL Warehouse (requires to visit warehouse with certain frequency).