Purpose of the Job : - Identify existing deviations, take corrective actions and prevent recurrence. - Take pro-active actions to Quality Assurance aspects. - Drive improvement projects. Requirements: Education : Degree in Engineering or Software (e.g. mechanical engineering, electrical engineering, industrial engineering) Work Experience : - Minimum 5 years of professional experience, preferably in the Medical Device industry - Experience in Quality Assurance, Regulatory Affairs, Software Development - Experience in applying Quality methods and tools - Preferably experience in working with agile methods - Preferably experience in working with digital solutions, e. g. workflow based CAPA process. Specific Knowledge/Skills : - Expertise in national and international Medical Device standards and regulations, Regulation (EU) 2017/745, ISO 13485:2016, MDSAP, MPDG, Directive 93/42/EEC, etc. - Communication skills - Problem solving skills - Decision making skills - Analytical skills - Project Management - Data-driven decision-making - Trainer skills - At minimum fluent in English. - Knowledge of German is an advantage. Main tasks: - Planning, inspection and reporting of Deviations and Supplier relevant topics to identify possible hazards and recommend corrective and preventive actions. - Pro-actively manage Non-Conformity and CAPA processes and determine root causes. - Ensure timely and risk-appropriate processing. - Oversee complaint management activities and address incidents as required. - Drive the process of Supplier Qualification and approval. - Evaluate, create and negotiate Quality Assurance Agreements (QAA) - Initiate and participate in regular team meetings with other team members with focus on Quality Assurance, e. g. Deviations. - Conducting training sessions for all employees to ensure that they understand how to perform their job to assure safety, performance, and efficiency. - Writing, reviewing and approving Work Instructions or other relevant documents to assure QA aspects are being followed. - Monitoring processes regarding compliance to applicable regulatory requirements, e. g. outsourced production or services - Reviewing data from customers to identify potential problems with products or services and suggest improvements. - Monitoring and reporting of processes based on objective Performance Indicators. - Expert in data-driven processes, transfer from static manually available data in automatization to drive better decisions based on real-world data. - Identify business risks from compliance aspects in the field of responsibility in implementation before they become a problem. Risk Monitoring: - Initiation, planning and reviewing project objectives, timelines, and budgets to ensure that they are realistic and achievable. - Initiate Vigilance process and as required support Field Safety Corrective Actions, recalls, etc. - Initiation, monitoring, and follow-up on information about regulatory compliance. - Responsible for conducting internal and support external audits in the field of responsibility.

Bangalore

Supplier Quality Auditor - Regulatory Affairs - Medical Devices Industry 

Supplier Quality Auditor - Regulatory Affairs - Medical Devices Industry  ,Job Description for Supplier Quality Auditor - Regulatory Affairs - Medical Devices Industry  in Carl Zeiss India ( Bangalore ) Pvt Ltd in  Bangalore for (5-10) years of experience. Apply Now!

Job Description for Supplier Quality Auditor - Regulatory Affairs - Medical Devices Industry  in Carl Zeiss India ( Bangalore ) Pvt Ltd in  Bangalore for (5-10) years of experience. Apply Now!