Senior Quality Associate - Bogota, Colombia - Ortho Clinical Diagnostics
Descripción
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 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.The Opportunity
As the company continues to grow, we are seeking a Technical Director for Colombia to implement and maintain the Quality Management System across region.
Responsible for Reactivovigilance and Technovigilance 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.
In addition, performance of quality audits (internal and external for distributors/3PL) is required, along with relationship management of regulatory consultants and regulatory authorities across the North LATAM region (direct and indirect markets).
Major Duties & Responsibilities
- Support management of the quality system: perform quality audits, develop/maintain SOPs and Quality agreement generation and drafting across region.
- Inspection and release of product in Colombia and release of product in Panama according to OCD procedures and local regulations.
- Coordinate and execute field actions according to Ortho corporate and local regulatory requirements; perform complaint handling and reporting to MoH; CAPA and communications with customer.
- Support the INVIMA CCAA process and Reactivovigilance and Technovigilance activities, including adverse event reporting.
- Communicate with Supply Chain, Marketing and Commercial regarding technical/quality information as necessary. Support key local crossfunctional projects with QRA expertise (i.e. 3PL transition, cold chain validation, etc).
- Maintain all Quality data bases up to date.
The Individual
- Pharmacist
- 35 years experience in quality in the medical device and/or IVD industry
- Intermediate in English
- Strong knowledge of Colombian compliance requirements, ISO13485 standard and relevant technical and procedural regulatory guidance documents applicable to IVDs.
- Highly proficient in the requirements of relevant policies and guidance documents as applicable to the regulation of IVDs in Colombia and North region.
- Excellent verbal, written and presentation skills
- Experienced in problemsolving, negotiation, and project management.
- Proficiency in working with an electronic document management system (DMS).
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