• Quality System Engineer / Senior Jobs in Malaysia - 1010383

    Abbott Penang (Formerly Known as St. Jude Medical)
  • 3 - 5 Years
  • Malaysia - Penang
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  • Posted above 1 month
  • Job Views: 30
  • Job Applicants: Less than 10

Job Description

Job Description

Provide insight to improve processes and practices to ensure Quality Management System is maintained while efficiency is optimizedCoordinate and prepare for audits and inspections by corporate, notified bodies and regulatory agenciesPerform quality assessment to ensure Quality system compliance to Standards and RegulationManage effective investigation and action plans in response to audit discoveriesAssist in corrective and preventive action (CAPA) ManagementEstablish training material and conduct training sessions to promote awareness of good practices and regulatory requirementsSupports Divisional Regulatory Affairs, monitors and coordinates the approval process for Malaysia site submissionsSupport worldwide regulatory request for preparation and submissions of documentation for product registrationApply Manufacturing Certificate for affiliates eventually to support product registrationTracks and submits documents for legalization and/or authentication as necessaryCoordinate, compiling and develop a database for product release authorization and ensure latest product release status are being maintainedAssist in investigation of all requests/questions and the generation of appropriate replies or reports as required by applicable Regulatory BodiesProactively identify areas for improvement within area of responsibility and implement changes with minimal guidance

Job Requirement

Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Others, Science & Technology, Engineering (Bioengineering/Biomedical) or equivalentAt least 3 year(s) of working experience in the related field is required for this positionPreferably Senior Executives specializing in Quality Control/Assurance or equivalentFull-Time position(s) available

Profile Summary

Type:Company Job

Role:Senior Executive


Salary:Not Disclosed

Deadline:02nd Mar 2020

Company Profile

‘Build as if intended for my family’
Abbott Penang (formerly known as St Jude Medical), a companywith premier high-tech medical device company that develops innovative medical technology, products and services that improve the lives of patients all over the world. Our device is implanted into a human being every 3 seconds of every hour of every business day. Headquartered in St. Paul, Minnesota,Abbottis a global company with research, development and manufacturing facilities around the globe.
AbbottPenang (formerly known as St Jude Medical) was established in 2009 and has grown steadily, continuing to manufacture increasing volumes of high quality implantable life saving devices to achieve more than 1 Million life saving devices to-date!
AbbottPenang is also the site for regional Shared Services Centre, providing innovative solutions streamlining the way we provide services to our business to achieve world-class operational excellence.
If you are enthusiastic, passionate, dynamic and aspire to contribute towards smarter, safer, better technologies in saving lives, we would like to hear from you!

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