HR Lead at SigTuple
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SigTuple - Senior Role/Lead - QMS & Regulatory Affairs - Medical Device (3-7 yrs)
Position : Senior Engineer / Lead - QMS & Regulatory Affairs (Medical devices)
Location : Bangalore
Job Description :
- Responsible for ensuring established ISO 13485 Quality Management system being maintained effectively.
- Quality Compliance & Regulatory Affairs business for Medical Devices Industry.
- Create a strong base for quality function coupled with regulatory support in achieving the planned results in areas of development and manufacturing of IVDD, active medical devices in compliance to ISO 13485 and applicable international & Indian regulatory standards
- Should have 3-5 years of relevant Industry experience.
Area of Expertise:
- Establish, control and monitor quality management systems (ISO 13485) as per regulatory standards.
- Support Design Quality Function for IMDD & IVD Medical Device Manufacturers
- Plan, coordinate, and execute activities concerned with new product development, post marketing activities for medical devices
- Knowledge about Risk Management, Hazard Analysis, Compliance testing, Design transfer activities
- Design Verification and Validation function for Medical Devices
- Basic knowledge about regulatory compliance reporting
- Create periodic quality reports, supporting quality, operations, and engineering functions.
- Basic Knowledge regarding process validation protocols and reports.
- Basic knowledge regarding compliance testing with respect to ISO, IEC, AAMI requirements applicable to medical devices
- Support quality control activities including, but not limited to FMEA, FTA, Hazard Analysis etc
- Work with product requirements compliance as it relates to engineering, manufacturing, product support operations.
- Good understanding of statistical analysis activities, CAPA, Root Cause Analysis processes
Experience Required :
- 3-5 years of relevant experience in Medical Devices Industry.
- Educational Qualification - Engineering Graduate, preferably Electronics & Communication /Mechanical Engineering.
- Ability to read and understand Regulations independently.
- Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
- Basic understanding of design control, manufacturing, post marketing processes
- Basic knowledge about various ISO, IEC, AAMI standards related to MDD & IVDD directives.
- Should have an experience in Auditing as per QMS requirements.
- Basic understanding of FDA / EU / Indian & other national regulations is an added advantage.
- Working knowledge of an e-QMS is an added advantage.
- Six sigma experience will be added advantage
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