Quality Engineer
Job Description:
Responsible for: . Analyzing, collecting data, and providing accurate, documented information
about the status of quality . Verifying the correctness of quality related development results i
n compliance with the Quality Management Plan & authorize their release for medical devices
Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical
Device Regulation (European Union Regulation), Quality system regulation (US FDA) . Assessment
of completeness of Design history file and Device master records . Participate in reviews as per
QMS, external and internal audits Experienced in: . Product risk management & non-product
software validation processes for medical devices . Creation and maintenance of technical file/
summary technical documentation (STED) . Medical device development
Key Skills :
Company Profile
services, healthcare, communications,\r\n energy,
transportation, and consumer \r\nand retail industries.
Offering\r\n customized and cutting edge\r\n technology
solutions, innovation and value
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