Ortho Clinical Diagnostics

Quality Assurance Associate

Job Locations BR-SP-São Paulo
Posted Date 4 weeks ago(29/1/2018 10:46 PM)
Job Country

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.


Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

Perform QA activities, such as maintain and improve the Quality System, conduct internal and external audits, execute Field Action notifications, recalls and Technovigilance activities.


The Responsibilities

  • Maintain and improve the Quality System documents and realize other QS activities, such as internal audits and Quality Trainings.
  • Execute Field Action Notification and Recalls activities, as well as, reports to the Local Health Authority, when applicable.
  • Execute Technovigilance Activities and submit reports to the Local Helth 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.
  • Provide MDS to sales representatives for customers.
  • Provide origin CoA’s for customers, when required.
  • Support to third parties with quality information.
  • Perform other work related duties as assigned.


The Individual

  • Professional Degree: Pharmacy and Biochemistry, Pharmacy, Biomedicine or Biological Sciences degree.
  • Certified as internal auditor according the Brazilian GMP Regulation (RDC n° 16/2013).
  • At least 3 years of experience in IVD (In Vitro Diagnostic), 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.
  • English: Intermediate Level
  • Travel 25% - National: Santa Catarina


Equal Opportunity

At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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