Quality Assurance Specialist with Regulatory Expertise

hace 4 días


Tlaxcala, México Quidelortho A tiempo completo
Job Description

We are seeking a Quality Assurance Associate to join our team at QuidelOrtho, a world-leading in vitro diagnostics company. As a key member of our Quality team, you will play a vital role in maintaining and improving our Quality Management System (QMS).

The ideal candidate will have a strong background in Quality Assurance, with experience in performing internal and external audits, executing Field Action Notifications and Recall activities, and providing Quality Support to various departments.

You will be responsible for:

  • Maintaining and improving the QMS, including conducting periodic Technosurveillance reports to local Health Authorities.
  • Supporting other QMS activities, such as internal/external audits and Quality trainings.
  • Executing Field Action Notifications and Recall activities, as well as reporting them to local Health Authorities when applicable.
  • Providing Quality Support to the Sanitary Responsible and Technosurvillance Responsible.
  • Supporting Local Authority Inspections.
  • Supplier Qualification and follow-up.
  • Providing Quality information and support to Supply Chain, International Trade, Marketing and Sales department.
  • Providing Quality documents and information when requested by customers.
  • Providing material safety data sheets to Sales Representatives for customers.
  • Providing origin CoAs for customers when required.
  • Supporting third parties with Quality information.
  • Supporting Warehouse quality assurance operation as needed.

In return, we offer a competitive salary range of $80,000 - $110,000 per year, depending on your experience and qualifications. We prioritize actions that support happiness, inspiration, and engagement, believing that employee happiness and business success are linked. Our team is dedicated to transforming the power of diagnostics into a healthier future for all.

Requirements include:

  • 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 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.
  • 3PL Warehouse requires visiting warehouse with certain frequency.


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