Quality Assurance Specialist
hace 1 mes
QuidelOrtho, a world-leading in vitro diagnostics company, is seeking a Quality Assurance Associate to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products and processes.
Key Responsibilities:
- Perform Quality Assurance activities, including maintaining and improving the Quality Management System (QMS)
- Conduct internal and external audits, as well as technosurveillance activities such as executing field action notifications, recalls, and complaints
- Prepare and submit periodic Technosurveillance reports to the local Health Authority
- Support other QMS activities, including 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
Requirements:
- Major in Pharmacy, Chemistry, or Biochemistry, with at least 3 years of experience in Quality and/or Technosurveillance
- Certified as Internal Auditor and External Auditor ISO 9000
- At least 3 years of experience 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
What We Offer:
- A dynamic and supportive work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
About Us:
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.
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