Quality Consultant - Singapore - ISRC PTE. LTD.

ISRC PTE. LTD.

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

Responsible to provide consultancy and training in management system according to standards (ISO13485, ISO9001, SS 620, GDP, Healthcare)
- develop the iso management systems for clients to achieve the certification
- assist client to maintain compliance with the management system processes
- support client with 3rd party audits, 2nd party audit
- conduct internal audits
- assist client with product registration activities with regulatory bodies
- responsible to verify effectiveness of QMS by internal audits.

Requirements:

Minimum 4-5 years proven medical devices industry experience

Knowledge of HSA medical device regulatory requirements (preferred)