Profile Details

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USD 60 /hr

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Hire Tamil S.

India

USD 60 /hr

5 years experience as an Quality Assurance professional.

Profile Summary

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

Subject Matter Expertise

• ★ 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)

Services

• Writing

Writing Clinical Trial Documentation, Technical Writing

Work Experience

Quality Assurance lead

ABM Respiratory care

January 2017 - August 2022

Education

Bachelors of Engineering

sona college of technology

May 2012 - May 2016

Certifications

• Quality System regulation 21 CFR 820

  ABM Respiratory care

  August 2019 - Present

• ISO 13485

  ABM Respiratory care

  August 2018 - Present