Technical Director and Quality Engineer
hace 4 días
Relocation Assistance Offered Within Country
Job Number #164086 - Cali, Valle del Cauca, Colombia
Who We AreColgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name
Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.
Job Summary:Ensure that Colgate-Palmolive Colombia (Plant and Distribution Center) complies with the sanitary regulations necessary to operate and commercialize the company’s products in the Andean region. Act as the Technical Director for the Colombian health authority, ensuring that the site complies with all sanitary regulations and effectively follows Good Manufacturing Practices (GMP) guidelines applicable to Colgate, specifically for Cosmetic Products, Medical Devices, and Household Hygiene products. Oversee the management of external and supplier audits by third parties (ESM), from preparation to the final closure of findings. Support the Customer Service & Logistics (CS&L) area of Colgate-Palmolive, ensuring Quality Assurance in Warehouses and the Distribution Center.
Essential Functions:- Ensure detailed knowledge of the sanitary regulations for Cosmetic Products, Medical Devices, and Household Hygiene products applicable to the site, and lead regulatory support for gap analysis in response to regulatory changes.
- Lead external audits conducted by regulatory agencies, ensuring timely preparation and closure of activities.
- Implement activities to ensure compliance with sanitary regulations for Cosmetic Products, Medical Devices, and Household Hygiene products at the site.
- Actively participate in ensuring compliance with the Quality Master Plan (Internal Audits, Evaluations, Training, Audits of co-packers, contract manufacturers, and/or suppliers) as required.
- Support and monitor Quality Assurance activities in Warehouses, Distribution Centers, and contract manufacturers.
- Ensure the closure of third-party supplier audits by ESM from a quality perspective.
- Manage and lead special projects within the department as required.
- Lead Quality Assurance activities with contract manufacturers.
- Provide support and leadership for external audits conducted by INVIMA, SIC, or other health and regulatory authorities, including ESM audits performed by a third party.
- Conduct Gap Analysis for any updates to sanitary regulations in conjunction with the Regulatory team.
- Ensure compliance with sanitary standards for Cosmetic Products, Medical Devices, and Household Hygiene products at the Colombian site.
- Perform Techno-vigilance activities as required by INVIMA.
- Be responsible for handling complaints and product recalls of medical devices from the market, reporting and following up on adverse incidents with the health authority.
- Provide technical advice to the legal representative regarding the characteristics of medical devices and ensure compliance with the current regulations concerning their quality.
- Ensure the technical and regulatory requirements of medical devices are met (by transporters, suppliers, etc.).
- Ensure medical devices stored meet established conditions, maintain proper documentation and records.
- Approve procedures related to storage, conditioning, dispatch, and distribution operations of medical devices.
- Ensure ongoing training of personnel according to needs.
- Verify that storage, conditioning, and distribution records are completed at each stage of the process.
- Record, analyze, and manage all adverse events or incidents potentially caused by a medical device.
- Recommend preventive measures and take immediate action when an event occurs.
- Guide informants in correctly filling out report forms.
- Raise awareness among users and potential reporters within the organization about the Techno-vigilance Program, the safety, and proper use of medical devices.
- Immediately report any serious adverse event or incident to the National Institute of Surveillance of Medicines and Foods (INVIMA), as required by the resolution.
- Submit periodic reports quarterly to INVIMA or to the Departmental and District Health Secretariats for all non-serious adverse events or incidents, as required by the resolution.
- Ensure storage conditions for medical devices comply with regulations, and maintain proper reports.
Achieving our purpose starts with our people — ensuring our workforce represents the people and communities we serve —and creating an environment where our people feel they belong; where we can be our authentic selves, feel treated with respect and have the support of leadership to impact the business in a meaningful way.
Equal Opportunity EmployerColgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.
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