Indeed
Quality Specialist/Technical Director
Position Summary:
Lead and coordinate maintenance and improvement activities of the Quality Management System and regulatory compliance in Peru.
Key Highlights:
1. Lead within a global medical technology company.
2. Drive the healthcare world with innovative solutions.
3. Be part of a team passionate about clinical improvement.
**Job Description Summary**
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Do you want to join a global leader in medical technology that acts to advance the healthcare world? Be part of something great!
BD is one of the largest medical technology companies in the world. We hold a unique market position with solutions designed to improve disease management and care management, supporting customers, healthcare professionals, and patients in enhancing clinical practice. Globally, we are more than 65,000 employees passionate about what we do, and we are committed to advancing the healthcare world with solutions spanning from diagnosis to treatment.
Lead and coordinate activities related to the maintenance and improvement of the Quality Management System (QMS) and tasks required for compliance with current Peruvian health regulations governing medical devices and in vitro diagnostic reagents.**Job Description**
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1. Train and raise awareness among BD Peru associates regarding the importance of meeting customer requirements and their commitment to the QMS, as well as guide documentation, maintenance, control, and improvement of the QMS.
2. Schedule and coordinate the execution of internal and external audits of the organization’s QMS.
3. Monitor the implementation and deployment of preventive and corrective actions within the Organization’s Management System.
4. Fulfill the functions defined for the Technical Director under current regulations on Good Storage, Transport, and Distribution Practices for Medical Devices and In Vitro Diagnostic Reagents.
5. Administer, manage, and monitor the company’s technovigilance program concerning reports of quality issues, incidents, and adverse events submitted to customers and regulatory authorities.
6. Ensure proper compliance with regulatory authority requirements.
8. Will be responsible for implementing, maintaining, and participating in matters stipulated in Quality Management Systems and the Occupational Health and Safety Management System.
Requirements:
– Degree in Pharmaceutical Chemistry
* Studies in quality management system implementation and quality audits, and current health regulations.
* English language proficiency.
* Minimum 4 years of experience in supervisory roles within the quality and technical direction areas.
*"BD values workplace equity and does not discriminate against any disability, class, ethnicity, age, religion, gender identity, or sexual orientation".*
Required Skills
Optional Skills
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**Primary Work Location**
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PER San Isidro \- Lima**Additional Locations**
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**Work Shift**
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Av. Los Conquistadores 367, San Isidro 15073, Peru