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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Bogotá, Distrito Capital, Colombia
Job Description:
Essential duties and responsibilities:
According to the Business requirements and leading strategy the main activities of this role can be some of the above:
Ensure compliance with company policies, procedures, and quality standards. Support investigations of non-conformances and definition of preventive and corrective actions through the analysis of root causes and participate in the meetings with the other areas involved.
Manage the training process, ensuring compliance with the metric defined for timelines and completion and complying with the minimum requirements established in the Curriculum Matrix.
Support the document control and records management processes, ensuring compliance with the company procedures.
Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation. Technovigilance Surveillance Responsible: Manage and report to health authority serious and non-serious adverse events related to medical device, as provided in resolution 4816 of 2008.
Support the process related to the technology-controlled reports, Quarterly Reports, traceability according to the frequency established by health authority. Support the Product Complaint process in Colombia and support the Post-market surveillance program Responsible for local product discontinuation and NPI (New product introduction) processes.
Interaction with manufacturing plants to manage local reconditioning in compliance with the company's Repack & Relabel requirements.
Responsible for monthly CAPA and Non Conformances governance.
Deployment of recall, stop shipment and sanitary alerts processes as required by Quality Management. Support the samples management process including samples for human use and non-human use.
Support the creation of the purchase orders relative to the process in the Commercial Quality area.
Perform handling material data transactions in SAP. Support with all relevant aspects during the receipt of local or external Regulatory Bodies inspection. Support local and regional projects that have impact on the Quality Management System.
Support the collection of product complaint samples.
Responsible for the shipment to the operating company of product complaint samples.
Support the Safety Datasheets requests and franchises submission.
Support the onboarding process.
Support the process for implantable card.
Support with relevant aspects during the receipt of Internal Audits Support Local RIM activities.
According to the backup system established, in case that would be required, the Commercial Quality Sr Supervisor or Specialist will support the activities described in this job description.
Essential knowledge and skills:
Minimum 2 years of work experience is required in Quality Systems (Good Manufacturing Practices) preferably in medical devices companies. A bachelor's degree is required. A degree in science, engineering, chemistry, pharmacist, administration or related field is preferred.
English B2.
Operation of Microsoft Office.
Knowledge on SAP are desirable Quality System courses are desirable
**Required Skills: **
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing