Quality Compliance Analyst (Fixed term)-00000SFA
Description
Quality Compliance Analyst-00000SFA
“Johnson & Johnson companies are equal opportunity employers”
Descripción:
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care
Searching the best talent for: Quality Compliance Analyst
Position general description:
- Ensure the compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company and the distribution channels and requirements indicated by Local Quality Regulations
- Guarantee the quality of our products, safety of our employees and respect for the Environment.
- Support compliance with J&J quality policies, quality legal requirements, quality agreements and quality clauses in contracts in each distributor operation.
Main responsibilities:
1. Ensure the compliance with J&J guidelines of the personnel at the Marketing Company.
2. Manages the Product Complaint process and support Post market surveillance program,.
3. Support the Compliance Alerts process (Stop Shipments and Recalls).
4. Identifies, corrects and eliminates compliance gaps.
5. Ensures that the products sold and distributed in its region are according to the regulatory requirements and J&J policies dealing with Quality, Health & Safety and Environmental
6. Supports the investigations of non conformances and the definition of preventive and corrective actions through the analysis of root causes and participates of the meetings with the other areas involved.
7. Support the other areas in supplier’s management, internal and external audits and in related matters to the quality of our products.
8. Support training activities with Supply Chain, sales force and distributors.
9. Deploy and implement the Quality System procedures and good practices at warehouse through Supply Chain in alignment with CLS.
10. Ensures the compliance with J&J quality policies of the indirect channel: Distributors.
11. Support the Internal Audit program in for the distribution channels and Market Quality.
12. Help with all relevant aspects during the receipt of local or external Regulatory Bodies inspection.
Calificaciones
- Profesional Graduated ideally with expertise in Quality Systems, 1 - 2 years Experience in Quality.
- High level of English
Global Leadership Profile Competencies
- Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
- Strategic Thinking ~ driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; motivated to leave things better than they were; a change agent
- Big Picture Orientation with Attention to Detail ~ able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed
- Organization & Talent Development ~ motivates and empowers others to achieve a desired action; enjoys developing a diverse group of people; instills confidence; attracts good people; brings out the best in others; invests time to be personally “connected” with the organization
- Intellectual Curiosity ~ sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty
- Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
- Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed
- Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
- Self-awareness and Adaptability ~ resilient; has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable
- Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
Other Considerations
5% travel
Submit your resume by: August 13th 2014
Primary Location
Bogota, Colombia
Organization
MD&D J&J
Ubicación principal: America Latina-Colombia-Distrito Capital de Bogotá-Bogotá
Organización: Johnson & Johnson de Colombia S.A. (7755)
Área: Quality Assurance
Description
Quality Compliance Analyst-00000SFA
“Johnson & Johnson companies are equal opportunity employers”
Descripción:
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care
Searching the best talent for: Quality Compliance Analyst
Position general description:
- Ensure the compliance with J&J policies and procedures described in the Quality Management System applicable to the Marketing Company and the distribution channels and requirements indicated by Local Quality Regulations
- Guarantee the quality of our products, safety of our employees and respect for the Environment.
- Support compliance with J&J quality policies, quality legal requirements, quality agreements and quality clauses in contracts in each distributor operation.
Main responsibilities:
1. Ensure the compliance with J&J guidelines of the personnel at the Marketing Company.
2. Manages the Product Complaint process and support Post market surveillance program,.
3. Support the Compliance Alerts process (Stop Shipments and Recalls).
4. Identifies, corrects and eliminates compliance gaps.
5. Ensures that the products sold and distributed in its region are according to the regulatory requirements and J&J policies dealing with Quality, Health & Safety and Environmental
6. Supports the investigations of non conformances and the definition of preventive and corrective actions through the analysis of root causes and participates of the meetings with the other areas involved.
7. Support the other areas in supplier’s management, internal and external audits and in related matters to the quality of our products.
8. Support training activities with Supply Chain, sales force and distributors.
9. Deploy and implement the Quality System procedures and good practices at warehouse through Supply Chain in alignment with CLS.
10. Ensures the compliance with J&J quality policies of the indirect channel: Distributors.
11. Support the Internal Audit program in for the distribution channels and Market Quality.
12. Help with all relevant aspects during the receipt of local or external Regulatory Bodies inspection.
Calificaciones
- Profesional Graduated ideally with expertise in Quality Systems, 1 - 2 years Experience in Quality.
- High level of English
Global Leadership Profile Competencies
- Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people
- Strategic Thinking ~ driven to envision a better future; takes any role or job and makes it better; has relentless dissatisfaction with status quo; makes the customer central to all thinking; keeps the focus on driving customer value; motivated to leave things better than they were; a change agent
- Big Picture Orientation with Attention to Detail ~ able to operate in two “worlds” simultaneously e.g., growth and cost control, enterprise and operating company success; sees the why as well as the what; can zoom in or out as needed
- Organization & Talent Development ~ motivates and empowers others to achieve a desired action; enjoys developing a diverse group of people; instills confidence; attracts good people; brings out the best in others; invests time to be personally “connected” with the organization
- Intellectual Curiosity ~ sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty
- Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset
- Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed
- Prudent Risk-taking ~ inner confidence to take risks and learn from experience; courage to grab opportunities or shed non-viable businesses
- Self-awareness and Adaptability ~ resilient; has personal modesty and humility; willing to learn from others; patient, optimistic, flexible and adaptable
- Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
Other Considerations
5% travel
Submit your resume by: August 13th 2014
Primary Location
Bogota, Colombia
Organization
MD&D J&J
Ubicación principal: America Latina-Colombia-Distrito Capital de Bogotá-Bogotá
Organización: Johnson & Johnson de Colombia S.A. (7755)
Área: Quality Assurance