HireDiversity

Ciudad de México, MX

Quality Engineer-000009KK

Description

"Las Compañías de Johnson & Johnson ofrecen a todos los candidatos igualdad de oportunidades de empleo"

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Company description:

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 Engineer

General description:

Ensure all activities related to the design, implementation, control, follows up and improvement of the Quality System at the 3PL operation are aligned to the J&J Quality Policy and the MOH requirements and Local Health Regulation, as well as, provide support in the implementation of the Quality System at the Market Company.

Functions:

· Ensure full implementation of Quality System and all associated Corporate Standards at the MD&D Distribution Center (3PL operation)

· Ensure everybody in the J&J operation meets the Good Warehousing Practices according to the Reglamento para Insumos de Salud (RIS), Normas Oficiales Mexicanas (NOMs), and any other Local Regulation

· Design and provide training in the current Normas Oficiales Mexicanas, CMS and Good Warehousing Practices.

· Provide support to the Health Responsible before MOH (Sanitary Responsible) activities when she/he is out of town/office

· Receive any Inspection / Visit from the Heath Authority

· Report to the Q&RC Manager, as well as, CLS and 3PL Managers any activity that may present risks within the J&J operation or within the 3PL facility.

· Responsible for implementing the following systems in an effectively manner, in both 3PL and Market Company: CAPAs, Validation & Qualification, Change control, Risk Management, SOPs, Measurement of QS

· Provide training to the CLS and Market Company personnel about quality systems assigned (CAPAs, Validation, Change Control, Risk Management and SOPs), and participate in any other training, as needed.

· Participate in Corporate Audits (ERC or SRC) to ensure successful results

· Take responsibilities as back up for the Product Complaint and Compliance Alert systems in Mexico

· Provide support for elaborating the Certificate of Conformity required in a timely manner

· Take responsibilities from the Quality Stand point for any contract manufacturer (repack & relabeling contractor) used by MD&D Mexico.

· Has authority to stop any process that is a high potential risk for quality product or regulatory aspect.

· Participate with CLS, 3PL and Market Company people to improve Quality Systems and process.

Reports to: Quality Compliance Manager

Cualificaciones

Qualifications:

• Bachelor of Science Graduated on: Chemistry, Biochemistry, Biology, Engineer or any other similar Bs in the medical-biological field

• Field: Pharmaceutical and/or Medical Devices

• English: at least 80%

• At least 5 years of experience in related area and 2 years of experience in Quality Assurance Systems (GMPs, Validation, etc)

• Experience in QA audits, data analysis, solving problems methodology and SOPs preparation, root cause analysis.

• Specific Knowledge: GMPs, GLPs, Good Storage Practices, Maintenance, NOM 059, NOM 137.

• Validation, process documentation and Statistical knowledge are desired.

Personal skills:

Influence and leadership skills

Tolerance to pressure & tenacity

Communication skills

Global Leadership Profile Competencies:

· 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
- 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
- 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

Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México

Organización: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)

Área: Quality Assurance