Job
Description
Roles and Responsibilities
- The Quality Assurance is an experienced person within the medical device industry with extensive knowledge performing their function
- Preparation of dossier for US & Europe
- Coordination with cross function team and review of technical documents
- Preparation of QA documents as per -ISO 13485:2016/ISO 9001:2015, and knowledge CE, FDA 21CFR, MDR requirement.
- Asist in documentation compilation such as device master file, technical file, CER,BER,ERs, risk analysis.
- Provided QMS services to clients based on ISO 13485:2016/ISO, 9001,2015 FDA 21CFR.
- Identify relevant guidelines documents inter national standards,
Desired Candidate Profile
Bsc/ Msc
Good written and oral communication skill are desired
Operating systems- Windows XP and Windows Professional.
Female Married Candidate will be preferred
Local Candidate will get extra advantage
Perks and Benefits
Best in the industries or as per current salary