Business Quality Analyst

hace 2 semanas

Bogota, Colombia Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.

We are in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

**We are searching for the best talent for COMMERCIAL QUALITY ANALYST to be in Bogota.**

**Purpose**:Ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company, distribution channels and requirements indicated by Local Quality Regulations. Establishes and maintains quality assurance programs, procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Ensure compliance for training and qualification program, records management and document control, change control process and samples management for human and non-human use. Ensure compliance with J&J policies and procedures described in the Quality Management System applicable to the role and also requirements indicated by Local Quality Regulations.

**You will be responsible for**:

- Ensure compliance with company policies, procedures, and quality standards.
- Support investigations of Quality Issues 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.
- Responsible for local product discontinuation and NPI (New product introduction) processes.
- 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 onboarding process.
- Support with relevant aspects during the receipt of Internal Audits

**Qualifications**:
**Qualifications and requirements**:

- 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, administration, or related field is preferred.
- English 50%.
- Operation of Microsoft Office.
- Knowledge on the TrackWise platform and SAP are desirable
- Quality System courses are desirable

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