Ortho Clinical Diagnostics

Distribution Quality Supervisor

Job Locations BR-SP-São Paulo
Posted Date 4 weeks ago(31/1/2018 7:30 PM)
ID
2018-4943
Job Country
Brazil

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

Provide quality and compliance oversight to Ortho 3PLs and distributors within and across LATAM.  Play a key role in distributor selection and lead on-boarding, including quality auditing and follow-ups to ensure distributor qualification.

Support Ortho 3PLs and distributors with Quality activities and products disposition. 

The Responsibilities

  • Work on supplier controls based on the Ortho procedure for supplier selection and approval, including Quality audits when applicable. – 20%
  • Establish risk-based methodology for distributor oversight. – 20%
  • Implement supplier controls (e.g. Supplier Quality Agreement, Supplier Audits, Business Reviews, etc) based on the Ortho procedures for supplier management. – 20%
  • Act as Regional Representative for providing guidance to distributors in relation to non-conformances, CAPA and changes. -10%
  • Responsible for alignment of Distributors Quality Management Systems with the requirements of the Ortho QMS. – 10%
  • Provide quality oversight for pack-out qualification, environmental systems, product disposition, and NC/CAPA investigation relating to all distribution activities (cold chain and ambient storage, handling, transport. – 10%
  • Provide support to routine warehouse quality management including the batch release \ defects verify \ label and IFU control. -10%

The Individual

  • Technical degree, or diploma in Pharmacy and Biochemistry, Pharmacy, Biomedicine, Quality Engineering.
  • Certified as lead assessor according  ISO standards (9001/ 13485)
  • At least 4 years of experience in IVD (In Vitro Diagnostic), or Medical devices industry in Distribution Quality and advanced knowledge in quality regulations.
  • Advanced user in Microsoft office and internet and knowledge in SAP system QA/ SC transactions.
  • Spanish: fluent
  • Portuguese: fluent
  • English: intermediate level.
  • Travel Up to 50%

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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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