Senior Quality and Technical Associate

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 6000 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.

We are recruiting a Senior Quality & Technical Associate to be based in Bogota / Colombia.

This position will perform the operative duties of Quality activities focused in the implementation and maintenance of the Quality systems across region in compliance of local regulations acts as technical responsible before INVIMA in Colombia. Also is responsible for post-market surveillance activities field action and complaint-handling activities acknowledgment letters to customers support for non-conformances and CAPA product release support for development of quality SOPs and due diligence for quality agreements performance of quality audits internal and external for distributors/3PL (direct and indirect markets).

What you will be doing:

• 20% - Support management of the quality system: perform quality audits develop/maintain SOPs and Quality agreement generation and drafting across region

• 10%- Inspection and release of product in Colombia and release of product in Panama according to procedures and local regulations

• 10%- Coordinate and execute field actions according to Ortho corporate and local regulatory requirements; perform complaint handling and reporting to MoH; CAPA and communications with customers and distributors

• 10%- Support the INVIMA CCAA process and Reactivovigilance and Technovigilance activities including adverse event reporting

• 20%- Perform functions and responsibilities as Technical Director in Colombia in compliance with the Decree Decree ResolutionResolution and Resolución 2013

• 10%- Communicate with Supply Chain Marketing and Commercial regarding technical/quality information as necessary. Support key local cross-functional projects with QRA expertise (i.e. 3PL transition cold chain validation etc)

• 10%- Support Distributors onboarding across region

• 10%- Maintain all Quality data bases up to date

What you need to be successful:

• Education: Pharmacist or Bacteriologist with professional license for Technical Responsible.

• Minimum of 5 years of experience in the medical device/IVD industry including areas such as manufacturing quality logistics and/or regulatory affairs

• Experience as a Technical Director for IVD and medical devices

• Technical Skills: Experience in Quality Logistics CCAA; knowledge in sanitary normative

• People Management: Trains employees; reviews work quality and quantity of others

• Soft Skills: Communication prioritization attention to detail problem-solving

• Travel: 15% by airplane or automobile; domestic and/or international

Language: Fluent in Spanish; English (intermediate verbal and written comprehension)

Why Join QuidelOrtho

At QuidelOrtho youll be part of a purpose-driven company that is transforming diagnostics and healthcare worldwide. We value innovation collaboration continuous learning and the unique perspectives our employees bring every day.

This is more than a job its an opportunity to grow your career while contributing to work that truly matters.

#LI-IZ1

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1