Commercial Quality Specialist

hace 2 semanas

Bogota, Colombia Johnson & Johnson A tiempo completo

Johnson & Johnson MedTech is recruiting for a(n) COMMERCIAL QUALITY SPECIALIST, located in Bogotá Colombia.

Responsible for supporting end-to-end quality operations within the North Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson. Establishing/maintaining quality assurance programs verifying that products meet their specifications and ensure that all elements of the QMS follow the requirements of applicable local regulations. Being the health representative of the company to the Health Authorities and the customers.

**Key Responsibilities**:

- Provide technical advice to the legal representative and areas of the Business, Technical Service, Planning, Regulatory, Deliver, among others, regarding the characteristics of Medical Devices, as well as meeting all the requirements of local regulations regarding the quality of MD, participating and leading continuous improvement projects to achieve efficiencies in the company by providing Quality concepts and ensuring compliance with company standards when applicable.
- Coordinate and supervise the distribution centers, monitoring and ensuring the implementation of both corporate and local regulatory guidelines and standards. When necessary, support the selection process of suppliers and distributors of the company.
- Ensure that the stored Medical Devices are under the established conditions.
- Create, update, review and approve procedures related to storage, conditioning, dispatch and distribution operations.
- Ensure that the staff is permanently trained and each training is adjusted to the needs.
- Verify that the records of the storage and conditioning processes are completed at each stage of the process.
- Guarantee the maintenance of the conditioning and storage areas and in general of all the facilities where operations with Medical Devices are carried out.
- Ensure that all verifications of processes, equipment and control instrument calibrations are carried out, as well as ensure that the records of each verification are included in reports and that reports are available.
- Ensure, through monitoring and control, the traceability of Medical Devices.
- Be responsible for the process of complaints and recalls of Medical Devices. As well as being responsible for supervising adverse events that may arise and reporting them to the Health Authority. Be responsible for giving decisions on the use of the products: Imported, conditioned, returned, rejected, recalled or falsified.
- Supervise compliance with the provisions established in the current regulations for Medical Devices, ensuring that any changes that impact product quality are properly evaluated and approved (specific to 3PLs)
- Be responsible for the inspection and/or packaging activities of Medical Devices.
- Be responsible for maintaining the quality of Medical Devices and represent J&J before the Health Authority.
- Supports the implementation of company standards such as: Temperature Control, Loaner Kit and Repack and Relabel Compliance, among others, as applicable.
- Provide support for the implementation and maturity of the quality management system of Commercial Quality, supporting the management of CAPA's, Non-Conformities, Change Controls, and ensuring the correct implementation of the other fundamentals of the quality management system.
- Report and display metrics / Dashboards for the quality indicators of Commercial Quality and 3PL, carrying out follow-up, analysis and/or trend monitoring activities.
- Supervise the product disposition process in the distribution centers in charge.
- Leadership, development, and supervision of the team in charge when applicable
- Participate and lead continuous improvement projects to achieve efficiencies in the company, supporting the concepts of Quality and ensuring compliance with company standards when applicable.
- Management of corporate and local tools that support the quality system (Windchill, Trackwise, Tru Vault, SAP, Curve, among others).
- Participate in the planning, execution, and reception of Quality audits of different types such as Internal, External, Regulatory, etc.

**Qualifications**:
**Qualifications**:
**Education**:

- Professional in Pharmaceutical Chemist, Biomedical Engineer, Surgical Instrumentalist, Chemical Engineer, Industrial Engineer or related careers.

**Experience and Skills**:
**Required**:

- 5 years of related experience in the pharmaceutical or medical device sector.
- Experience in the implementation of elements of the Quality Management System.
- Experience in leading Quality events such as Non-Conformities, CAPAs, Change Controls, etc.
- Experience in supervising 3PLs, managing and developing them.
- Experience as Technical Director - Qualified Person (desirable)

**Preferred**:

- Internal auditor certification in Quality Systems
- Required language: English advanced intermediate level, Portuguese is a plus.

**Other**:

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