Alcon Johor (known as CIBA VISION Johor Sdn Bhd) Vacancies Staff Engineer (Regulatory Compliance)
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.
Job Description
1. Leads audit and inspection preparation (e.g. corporate audit, Notified Body Audit, Health Authority Inspection etc.), resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
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.
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.
Role Requirements
• Bachelor degree in Engineering or Science.
• 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
• 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
Company Overview
Alcon Johor also known as CIBA Vision Johor Sdn. Bhd., located in Pelabuhan Tanjung Pelepas (PTP) Johor, was founded in 2005. The site is mandated to be the center of excellence for Double Sided Molding contact lens manufacturing platform for the entire Alcon globally.
Our passionate and talented associates focus solely on producing high quality sterile, world renowned, AIR OPTIX® soft contact lenses, for correction of refractive errors and/or for use as bandage lenses for more than hundred countries worldwide.
In Alcon Johor, we aspire to lead the world in innovating life-changing vision products because when people see brilliantly, they live brilliantly.
How To Apply
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