Director, Quality Assurance Operations / R&D
Singapore, Singapore
10d ago

Director, Quality Assurance Operations / R&D Description The successful incumbent is expected to : Oversee and manage all QMS processes that can impact product quality (including design control, validation, calibration, testing, sterilization, manufacturing control and complaint investigation) Drive all necessary action, product and production holds and ensure that product nonconformities are contained, investigated and corrected Oversee in close collaboration with other functions lean initiatives which improve product quality, improve process quality and reduce waste Manage external audits, including ISO, PDMA, CE and FDA Manage product and process quality related KPI's report status regularly Collaborate and participate in global QA projects such to facilitate company improvement Maintain FDA establishment license Interface and communicate effectively with the Medical Division regional quality teams Develop quarterly department budget, ensure spending is maintained within budget Leadership -

be the positive role model for factory employees relative to quality culture & continuous improvement Support the VP of Global Quality in the development and implementation of strategies for quality improvement All candidates meeting the following requirements are welcome to apply : Degree in Engineering or equivalent technical experiences Minimum 5 years of experience in management of Quality Systems in regulated industry, preferably in a multi-

cultural environment Experience in managing external audits of suppliers and regulatory bodies Experience in design control, manufacturing control, sterilization, analytical methods and environmental control Experience in successful management of teams of professional, preferably on different locations Proficient at process mapping, flow charts, database systems, Excel, Microsoft Office and automated quality systems Sound knowledge on global regulatory requirements for medical device industry Lean manufacturing and / or Six-

sigma experience preferred Country Singapore Company MNC Salary From US$60,000 Working Hours Full-Time Contract Permanent Categories Quality Assurance Industries null

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