Commercial Quality Analyst
hace 6 meses
Diversity, Equity & 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 MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
**We are searching for the best talent for Commercial Quality Analyst to be in Bogota, Colombia.**
**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**:
1. Ensure compliance with company policies, procedures, and quality standards.
2. 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.
3. 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.
4. Support the document control and records management processes, ensuring compliance with the company procedures.
5. Change Control execution process support, ensuring that the changes are evaluated, registered, reviewed, and approved prior to implementation.
6. Responsible for local product discontinuation and NPI (New product introduction) processes.
7. Support the samples management process including samples for human use and non-human use.
8. Support the creation of the purchase orders relative to the process in the Commercial Quality area.
9. Perform handling material data transactions in SAP.
10. Support with all relevant aspects during the receipt of local or external Regulatory Bodies inspection.
11. Support local and regional projects that have impact on the Quality Management System.
12. Support the onboarding process.
13. Support with relevant aspects during the receipt of Internal Audits
14. Support POLO(Product of local opportunity) complaints management.
**Qualifications**:
1. Minimum 3 years of work experience is required in Quality Systems (Good Manufacturing Practices) preferably in medical devices companies.
2. A Bachelor's degree is required. A degree in science, engineering, chemistry, administration or related field is preferred.
3. English 70%.
4. Operation of Microsoft Office.
5. Knowledge on the TrackWise platform and SAP are desirable
6. Quality System courses are desirable
- Strong written and verbal communication skills
- Management of complexity
- Planning and organization skills.
- Effective and assertive communication skills - Written and verbal.
- Ability to work under pressure.
- Skills for prioritization of activities and sense of urgency.
- Strong teamwork and connect skills
- Good communication skills in English and Spanish
Results oriented
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