R&D Engineer Needed

6 days ago

Shimoga, Karnataka, India beBeeResearch Full time ₹ 15,00,000 - ₹ 20,00,000

**Job Opportunity:**

  • We are seeking a highly skilled and experienced Research and Development Engineer to join our organization in India.

**R&D - Design Quality**

Roles and Responsibilities
  • Create a quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
  • Experience in Medical Device QMS processes.
  • Has ability to organize, drive rigorous compliance of and lead a successful QMS processes at a medical device facility.
  • Communicates complex messages and negotiates mainly internally with others to adopt a different point of view.
  • Uses high level of judgment to make decisions and handle complex tasks or problems that impact the site's compliance. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
  • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
Required Skills and Qualifications
  • Minimum of Bachelor's Degree. Experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from the scratch within a regulated industry.
  • Ability to effectively communicate technical information in English (both written and oral).
  • Experiences in the understanding & interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc for Class 2 and Class 3 devices

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