プロフィール詳細

プロジェクトを作成

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Tamil S.に依頼

India

5 years experience as an Quality Assurance professional.

プロフィール概要

5 years experience as an Quality Assurance professional.I have a broad background, topics include: - ISO 13485:2016 - 21 CFR 820 - ISO 14971, IEC 60601 - V&V and technical submissions for a range of medical devices - Responsible for authoring several 510(k) submissions for the FDA

専門分野

• ★ ISO 13485
• ★ ISO 14971
• ★ Quality Assurance & Quality Control (QA/QC)
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)

サービス

• Writing

Writing Clinical Trial Documentation, Technical Writing

職務経験

Quality Assurance lead

ABM Respiratory care

1月 2017 - 8月 2022

学歴

Bachelors of Engineering

sona college of technology

5月 2012 - 5月 2016

認定資格

• Quality System regulation 21 CFR 820

  ABM Respiratory care

  8月 2019 - 現在

• ISO 13485

  ABM Respiratory care

  8月 2018 - 現在