Summary As directed by the Quality Manager the Quality Engineer is accountable for supporting current product development and product maintenance through the application of Quality engineering skills for medical devices This person will handle projects and tasks from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies while meeting all design control and other regulatory requirements Educational Background Bachelor s degree in mechanical engineering biomedical engineering or related engineering discipline Professional Experience A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience Job ResponsibilitiesParticipates in design control activities of medical device products Ensures proper design and development control and its documentation as per ISO 13485 FDA QSR Quality System Leads or supports Risk Management in accordance with ISO14971 Contributes as a team member on development projects carrying out assigned quality assurance responsibilities in a timely diligent and professional manner Creates implements changes to and maintains controlled documents as needed e g SOPs Specifications Methods etc to ensure strict compliance of R D functional operation with ISO 13485 21 CFR 820 Quality System EN requirements Supports continuous improvement of the Quality Systems Applies Statistical tools to support product development process Provides QS knowledge to organization as needed Administers appropriate training as needed Participates in the ongoing operations of QA QS activities Knowledge and Skills KnowledgeModerate knowledge of medical device regulations and practices ISO 13485 FDA QSR etc Practical and demonstrated experience of Quality or Reliability engineering risk analysis product development and verification validation testing in the medical device industry Demonstrated hands-on experience with Design Control procedures Experience in a Phase-Gate development process Experience in directly applying statistical methods for quality improvement Moderate knowledge and understanding of process development total quality tools and continual improvement approaches SkillsGood technical writing skills Familiarity with statistical methods and analysis and or Minitab software Team player with excellent interpersonal and communication skills Desired Additional Skills Knowledge Not essential to the job but will be an advantage to possess Familiarity with Six Sigma methodology Disciplined and well-organized in documentation plans requirements drawings design reviews and test methods Strong critical thinking analytical and problem-solving skills Any additional Information Specially if needed for Quality or legal purposes Certified Quality Engineer Preferred Certified Six Sigma Green Belt and or Six Sigma Black Belt Preferred Required Skills Optional Skills Primary Work Location IND Bengaluru - Technology Campus Additional Locations Work Shift

📌 Quality Engineer (Karnataka)
🏢 BD
📍 Karnataka