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Bogota, Capital District, RAP (Especial) Central, Colombia • On-site
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The role focuses on implementing and maintaining quality systems and acting as the technical responsible party before INVIMA in Colombia. Key duties include performing quality audits, managing post-market surveillance, and coordinating field actions and complaint handling.
Candidates must be a licensed Pharmacist or Bacteriologist with 1-5 years of experience in the medical device or IVD industry. Proficiency in Spanish is required, with intermediate English comprehension skills.
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 – 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 47252005, Decree 37702004, Resolution 4002 2007, Resolution 48162008 and Resolución 2013038979_ 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, you’ll 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 — it’s an opportunity to grow your career while contributing to work that truly matters.
#LI-IZ1
Changing lives one test at a time – Connect with us and explore how we’re shaping the future of diagnostics.
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19. For decades, our precision and accuracy have guided clinicians and lab technicians in the moments that matter most. > Continuing our legacy in diagnostics Our portfolio serves the entire healthcare continuum: from high-volume, high-complexity hospitals and labs to point-of-care, retail and over-the-counter markets. This enables us to continue our legacy of diagnostics in an ever-changing environment where we're passionately pursuing the unknown to advance diagnostic science and care. > Raising the bar in diagnostic care Ranked among the world’s largest in vitro diagnostics (IVD) providers, we’re building on more than 120 years of collective experience and innovation. We combine industry-leading expertise in immunoassay and molecular testing with a global footprint in point-of-care settings, clinical labs and transfusion medicine to advance critical diagnostic solutions at scale. > Powering a healthier future for all Inspired by a spirit of service, QuidelOrtho is committed to enhancing the wellbeing of people worldwide and happy in the knowledge we are making a difference. To contact us, please visit https://www.quidelortho.com/global/en/contact-us. For career opportunities, please visit: https://careers.quidelortho.com/global/en. #QuidelOrtho #BetterTogether #PowerUpLabs #HealthierFuture #DiagnosticFrontier #AdvancingScience #TalentNetwork
There are currently 130 open logistics positions in Bogota, Capital District, Colombia listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Quala, Iron Mountain, UPS, Cencora, Essity, among others. Browse the listings above to see every active employer.
Yes — 27 of the 130 open logistics positions offer remote or hybrid work (5 remote, 22 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
