QRC Specialist
Há 5 dias
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.
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The role is based in São Paulo, Brazil, and is a fixed-term contract for 9 months with the possibility of extension or becoming permanent]
As we continue to grow as QuidelOrtho, we are seeking a fixed-term
QRC Specialist - São Paulo
to join our team, who will be responsible for maintaining and strengthening the Quality System, ensuring regulatory compliance, and providing quality support across internal teams, suppliers, and local health authorities, including technovigilance, audits, recalls, and inspections.
Your New Role
Perform QA activities, such as maintain and improve the Quality System, conduct internal and external audits, execute Field Action notifications, recalls and Technovigilence activities.
What You'll Be Doing In Your New Role
- Maintain and improve the Quality System (QS) documents and realize other QS activites, such as internal audits and Quality Trainings;
- Execute Field Action Notification and Recall activities, as well as, reports to the Local Health Authority, when applicable;
- Execute Technovigilence Activities and submit reports to the Local Health Authority;
- Provide Quality Support to the Technical Responsible for each branch;
- Support the Local Health 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;
- Perform other work-related duties as assigned.
The Individual
- Education: Pharmacy and Biochemistry, Pharmacy, Biomedicine or Biological Sciences degree
- Minimum Years of Experience: 3 years of experience in IVD (In Vitro Diagnostic) or Medical Devices industry in Quality Assurance
- Technical Skills: Advanced knowledge in quality regulations
- People Management: Trains employees; reviews work quality and quantity of others
- Soft Skills: Communication, prioritization, attention to detail, problem-solving
- Travel: 25% by airplane or automobile; domestic and/or international
- Language: Fluent in Portuguese; English (intermediate verbal and written comprehension)
- Familiarity with web-based content sharing applications (i.e., SharePoint), Microsoft Office Suite, Adobe (desirable)
- Knowledge in S4HANA system QA/SC transactions (desirable)
What We're Offering
- Competitive salary
- VR/VA (R$1.500,00 monthly)
- Global Bonus Plan
- Wellhub
- Profit Share
- Private Pension (Itaú)
- Life insurance (MetLife)
- Medical insurance (Bradesco)
- Dental insurance (Amil)
- Recognition Program and more
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