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Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations:

Mumbai, India

Job Description

Organize, plan and lead the execution and compliance related to Product Complaint

Management with proficiency in using the associated tools.

End 2 End Quality Management of Service and Repair center of J&J Service organization.
Knowledge and understanding of ISO9001:2015,ISO13485:2016, D&C Act,Legal Meterology Rules, MDR 2017.
Organize, plan and lead the execution and compliance related to quality system elements like Change control, Field Action and Escalations.
Support overall Training Management for J&J MedTech India including assignment, trouble shooting, ensuring training completion on time, coordinating with Cross Functional Team for training requirements, Training Matrix update, providing trainings, etc.
Effectively use the quality tools such as ECM, TruVault, EtQ, SUMMIT etc.
Execute / Support activities related to internal and suppliers’ audits to ensure compliance with regulatory requirements, company and international standards.
Organize, plan, lead and manage quality-related projects in alignment with Organization goals, as and when assigned.
Support activities related to document control, CAPA, NCR. systems and processes.
Shall actively participate in investigating the issues and document and follow up the action plans. Reviews reports findings and makes recommendations for corrective action.
Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections, internal and supplier’s audits as well as Corporate audits and coordinate responses.
Management Report preparation.

Required Skills

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

Johnson & Johnson MedTech

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