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| Job Location | Gurugram |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
The successful candidate will be actively involved in the development and engagement of the overall team ensuring the quality delivery of the project for product development and Process development. This includes oversight to Advance manufacturing and quality team following systems implementation including test and inspection plans and product reliability during product development, verification, validation and design transfer while working with Regulatory Affairs Department to ensure compliance to FDA Quality System Regulations and ISO 13485. Roles and Responsibilities Responsible for the timely and quality deliveries of the assigned tasks for his team. Work as point of contact for all project related aspects with the project team and other stakeholders. Ensure continual improvement in customer satisfaction, delivering higher value services and productivity. Managing partnerships with vendors and other SME s as needed. Contribute to absorption of new technologies, processes and methods. Develop an open culture to instill confidence, diversity of perspectives and knowledge sharing. Communicating frequently across all project stakeholders to ensure project team and senior management are aware of upcoming milestones and risks/ issues. Lead product quality related projects. Supports the business in addressing and solving quality problems Conduct internal audits & participate in corporate and FDA audits Support process validation programs for new product development Work with cross- functional/ cross cultural teams to develop regulatory guidelines and procedures Provide inputs for NPDP for adherence to QMS and Good Documentation practices Work with engineering & manufacturing teams to develop robust verification test strategies to ensure product safety and reliability. Supervisory Responsibility: Will supervise the project deliverables from Advance Quality and Manufacturing deliverables standpoint. Technical Skill SetUnderstanding of the concepts of PPAP, APQP, MSA, SPC, FMEA, Risk Management, Process Capability, Complaint Handling, Supplier assessment & control, Data analysis, Measurement systems, Pro- E, understanding of Design system and ability to read Design prints. Must be well versed with Design Controls for a New Product development cycle. Product risk assessment as per ISO14971 Well versed in New Product Development Process Good Knowledge of operations engineering Understanding of regulations applicable to devices, particularly standards. Knowledge of material selection, International standards, and norms. Responsible for inculcating Instruments Culture in the team., Education B. Tech / B.E / M. Tech / M.S. ME/ SW/ Bio- medical Engineering Experience: Experience: 8- 12 years Must have handled or lead teams of more that 6- 8 engineers. Must have handled Mechanical, Electronics, Software or electro- mechanical projects from as AME or AQE, for complete lifecycles of few significant projects. ,
Keyskills :
sales management mis customerrelations quality newproductdevelopment continuousimprovementfacilitation socialmedia dataanalysis internalaudit productsafety qualitysystem riskmanagement riskassessment productquality seniormanagement regulat