Alcon Johor (known as CIBA VISION Johor Sdn Bhd) is looking for new potential candidates to fill in for Staff Engineer (Regulatory Compliance) position. If you currently looking for new job opportunities and qualified with the job desc, feel free to apply this job.
2.Ensure timely preparation, review, approval and submission of any local/global quality metrics reporting.
3.Coordinate the site’s monthly Quality Council Meeting and bi -annual Quality Management Review meeting.
4.Responsible for maintenance of the site Quality manual.
5.Ensure Site Quality Objective and IMPACD gap assessment implementation is according to defined time line.
6.Participate in global initiative for cockpit dashboard/Quality Management Review improvement and remediation program by representing the Johor site.
7.Site Internal auditor – participate and conduct process audit as per schedule and procedure.
8.Provide support in any other Quality compliance activities.
• Minimum 7 years working experiences in manufacturing environment. Preferably, those has experiences working in Medical Device or Pharmaceutical Industries, with auditor background.
• Strong knowledge of cGMP, ISO 13485, MDSAP and applicable Medical Devices Regulatory Requirements (e.g. US FDA 21 CFR part 820, EUMDR 2017/745) document
How To Apply
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