STJobs | At STJobs, Your Ideal Job Isn't Hard to Find.

Senior QA Specialist (ASEAN) - Global Medical Device Company

MICHAEL PAGE INTERNATIONAL (SINGAPORE)
Posted On :13 Nov 2017

 

Job Summary

  • Salary:   Undisclosed
  • Work Type: Permanent / Full Time
  • Min. Education Level: Degree
  • Field of Study: Bioengineering, Civil Engineering, Pharmacy
  • Years of Experience: 5
  • Skills: Quality assurance, quality systems, medical devices, medical technology

Job Descriptions

  • Manage all post market regulations and pre market activity
  • Lead Quality Management Systems improvements

Client Details

One of the worlds largest medical device and technology organisations, the company has a vast portfolio of products cutting across different therapy areas and segments. An R&D focused organisation, it is looking to bring on board a Quality Manager to drive best practices through the region.

Description

Reporting to the Head - Quality & Regulatory, you will be responsible for:

  • Leading government safety alerts and corrective actions as well adverse event reporting with the local and manufacturing teams to ensure timely initiation and closures according to regulatory deadlines
  • Ensuring compliance to corporate and regulatory requirements such as ISO 13485 and GDPMD
  • Drive projects related to improvement of Quality Management System (QMS)
  • Manage internal and external audits on QMS, such as annual ISO 13485 audits
  • Providing regular updates on changes in regulations related to quality requirements in the region
  • Identifying gaps and risks, and then devising strategies to increase efficiency

Profile

  • 6 years experience in leading Quality Assurance with a strong knowledge of QMS
  • Well versed with ISO 13485 regulations with an experience in managing internal and external audits
  • Ability to work cross functionally with different teams and leaders

Job Offer

An opportunity to lead the Quality function work with one of the most renowned medical device organisations

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Tushar Dadhwal on +65 6419 5938.