Hr at DataGroup Geo spatial Technologies Pvt.LTD
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Associate Lead - Quality Assurance - Medical Devices (8-15 yrs)
Role : Associate Lead-Design Quality Assurance
Location : Gurgaon
Experience : 8 - 15 Years
CTC : 15 - 20 Lakhs
B.E (Mechanical)
Medical Devices Industry
Please don't consider candidates who are in Supplier Quality Assurance
Target Industries : Healthcare/Pharma/Biotech
About Company :
Our client is a leading US based MNC into manufacturing of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynaecology.
Job Description :
- Apply sound, systematic problem-solving methodologies using defined business systems (CAPA) to identify, prioritize, communicate, and resolve quality issues
- Act as an effective team member in supporting quality disciplines, decisions, and practices
- Execute in streamlined business systems to effectively identify and resolve quality issues
- Monitor field performance of recently launched and established medical devices against risk assessments
- Lead in the quality role of a cross-functional team to identify and implement effective controls and support changes to commercialized products to meet or exceed internal and external requirements
- Plan and support the verification, validation, and usability testing of changes to commercial designs to meet or exceed internal and external requirements
- Partner cross-functionally to identify and support value improvement efforts to support business goals
- Support product investigation report of products through competent authority communication
- Support post market surveillance of products through competent authority communication
- Update and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
- Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs) Support medical device audits from internal or external authorities
Qualifications : Bachelor of Engineering/ Bachelor of Technology
Working Days : 5 Days a week
Job Nature : Full Time
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