Manager Quality Assurance And Regulatory Affairs

Manager Quality Assurance And Regulatory Affairs QSA Surgical Pvt. Ltd, Pakistan

The QA & RA manager will be responsible for development and effective implementation of the company’s quality management system to fulfill requirements of ISO 9001 : 2008, ISO 13485 quality management systems and FDA’s 21CFR, Section 820 (GMP) quality system regulation for Medical Devices. Trainings will be provided by the company to the selected candidate for further understanding of ISO 13485 quality management system. Job Specification

The candidate should preferably have a master's in Total Quality Management and a B.Sc. in Mechanical Engineering and should be a lead auditor for ISO 9001 : 2008 / ISO 13485 quality management system. The applicant must have a minimum work experience of 5 years in system development, implementation, and audit of ISO 9001 : 2008 / ISO 13485 quality management system in a manufacturing industry. The applicant should also have good IT skills, be highly motivated & result-oriented, and should have strong leadership qualities. The compensation package will be attractive, based on qualification, experience and linked to Key Performance Indicators (KPI) which will be determined by the Board of Directors.

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