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Commercial Quality Specialist
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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 SPECIALIST to be in Bogota, Colombia**
**Purpose**:
Ensure the compliance with the policies and procedures of J & J described in the Quality Management System applicable to Johnson & Johnson, distribution channels and the requirements indicated by local regulation.
Establish and maintain quality assurance programs, procedures and controls, ensuring that the operating parameters of the products and quality system elements are continuously measured to drive improvement initiatives
**You will be responsible for**:
- Send the technology-controlled reports according to the frequency established by health authority.
- Lead the **Nonconformance **to Legal Manufacturer report execution process in the country.
- Manage the compliance of the field action and recall according to the requirements of the health entity, and the originator company.
- Document the Quality Issues and Non-Conformities in the **ETQ **platform; ensuring compliance with the different stages: identification, investigation, cause analysis, correction, implementation of corrective and preventive actions and verification of effectiveness
- Ensure compliance with company policies, procedures, and quality standards.
- Manage the **Product Complaint **process in Colombia, Northern cluster focal point. Support the Post-market surveillance program.
- Manage the **certificates of analysis **for the Medical Devices portfolio of products, previous importation of the goods.
- Bidding support as required.
- Purchase orders creation relative to the process in the Commercial Quality area.
- Support with relevant aspects during the receipt of local or external Regulatory Bodies inspection.
- Support with relevant aspects during the receipt of Internal Audits.
- Support Marketing area and Conduct inspections to Copy Review material for verification periodically.
- Coordinate the local Repack and Relabel activities.
- Manage complaint samples.
- Support product complaint process
- Technovigilance support and Surveillance Activities Manage and report to health authority any event or serious adverse event of a medical device, as provided in resolution 4816 of 2008,
**Qualifications**:
**Requirements**:
- Minimum 5 years of work experience in Quality Systems (Good Manufacturing Practices)
- Title of pharmaceutical chemist, life sciences, engineer or others related to health sciences with expertise in Quality Systems.
- English 80%
- Microsoft Office Management, PowerBI, Powerapps
