3 - 8 years
5 - 10 Lacs
Posted:1 week ago|
Platform:
Work from Office
Full Time
KA, IN
Associate - Quality Assurance-Design Control Lab Engineer
You will be responsible for:
Lab Test Method Validation and Transfer plans, protocols, and reports handling Lab testing protocols and reports Lab Test Requests handling Development, drafting review and maintenance of Design History Files (DHFs) related artefacts including but not limited to Design inputs Design verification plans Design verification protocols and reports Design and development plans Risk analysis Feasibility plans, protocols and final reports etc Development and review of risk management plans, reports, FMEAs;Ensure FMEA s are performed as required to mitigate risks in design, transfer, and manufacturing Performing gap assessment for DHF remediation and reporting out the findings Your impact: About you: Strong working knowledge of ISO 13485:2016 and/or 21CFR 820 Strong understanding of risk-based approach per ISO 14971 Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field. Strong flair and passion for technical writing. Excellent technical & med device product documentation skills Strong written and verbal communication/presentation skills Must have: Bachelors degree (B.E. B.tech) Minimum 3 years of experience in any of the following functions medical device development/regulatory-medical writing/developing/publishing medical content
Indegene
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