HR Lead at SigTuple
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SigTuple - Manager - QMS & Regulatory Affairs - Medical Device (7-20 yrs)
Position: Manager - QMS & Regulatory Affairs (Medical devices)
Responsible for driving 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 8-12 years of relevant Industry experience and proven leadership qualities.
Area of Expertise :
- Establish, control and monitor quality management systems (ISO 13485) as per regulatory standards.
- Support Design Quality Function for IVD Medical Device Manufacturers
- Plan, coordinate, and execute activities concerned with new product development, global product introduction, post marketing activities for medical devices
- Prepare and own compliance plan, Risk Management, Hazard Analysis, Compliance testing, Design transfer activities
- Drive Design Verification and Validation function for Medical Devices
- Develop and initiate methods and instructions for regulatory compliance reporting
- Create periodic quality reports, supporting quality, operations, and engineering functions.
- Collaborate with Engineering personnel in writing and reviewing process validation protocols and reports.
- Drive 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
- Summarize data using appropriate descriptive and inferential statistics. Collate, analyse and interpret statistical data for internal and external customers.
- Deep understanding of Reliability engineering, statistical analysis activities, CAPA, Root Cause Analysis processes
Experience Required :
- 8-12 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
- Knowledge of FDA / EU / Indian & other national regulations.
- Good understanding of design control, manufacturing, post marketing processes
- Certification in ISO, IEC, AAMI standards
- Should have an experience in Auditing as per QMS requirements.
- Working knowledge of an e-QMS is an added advantage.
- Six sigma experience will be added advantage
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