Develop and maintain quality system related to QA oversight of manufacturing processes.
Ensure product release operates as independent group (of all other operations) and ensures product release complies with documented specifications and regulatory expectations.
Ensure QC Operations is compliance with cGMP’s, ISO regulatory requirements and Alcon Quality Manual.
Manage deviations and investigations within QC and support manufacturing investigations as required.
Manage and control department budget and expenses and ensure adequate resources for full implementation of Quality Control Plans.
Develop and implement lens and product cosmetic standard.
Implement QA Engineering function to support and improve GMP practices throughout operations.
Accountable for HSE and BCM implementation and performance in the respective function. Provide leadership and responsible for other HSE activities that are assigned by Management.
Requirements
Minimum B.S. Engineering or Science (e.g. Chemistry, Biology, etc).
5 years of experience in the medical device or pharmaceutical industry.
Thorough knowledge of cGMP/QSR and ISO regulations.
Understanding of statistic, LEAN and Six Sigma principles.
Strong leadership, people skills and communication.
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