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[Expired] Executive (QA - Quality Management System / Regulatory Affairs)

Posted On :24 Sep 2013


Job Summary

  • Salary:   Undisclosed
  • Work Type: Permanent / Full Time
  • Min. Education Level: Degree
  • Field of Study: Science, Engineering (General)
  • Years of Experience: 2
  • Skills: • Excellent knowledge of IS013485 quality management system , Relevant experience in Quality Assurance, Support regulatory submissions and change notifications

Job Descriptions

Duties & Responsibilities:


  • Maintain and improve Quality Management System (QMS) to be ready for audit at all times. Support efforts for compliance to ISO 13485, international regulatory requirements and customer requirements
  • In charge of Documentation Control Centre, Company equipment registration, calibration and maintenance facilitation centre and QA training matrix
  • Responsible for supplier evaluation, corrective action reports, site audits and performance monitoring, to ensure the quality of incoming product impacting materials
  • Coordinate incoming materials release, and finished product shipment approvals
  • Review product quality performance metrics (e.g. yield and output data) on a regular basis
  • Coordinate and perform investigations for customer complaints on non-conforming product quality. Coordinate any investigations on Non-Conformance Reports (NCRs) and coordinate the fulfillment of Corrective Actions and Preventive Actions (CAPA)
  • Conduct training related to procedures, QMS and GMP
  • Assist in the coordination and conduction of internal audits to ensure compliance to regulatory and company requirements. Support activities required for external audits by customers, regulatory authorities and notified bodies
  • Support regulatory submissions and change notifications. Coordinate updates of product master file and maintenance of device master record
  • Perform any other related duties as assigned by immediate superior

Minimum Requirements:


a)    Education & Training

  • Degree in Science, Engineering or relevant disciplines 

b)    Experience

  • Minimum 2 years of relevant experience in Quality Assurance
  • Excellent knowledge of IS013485 quality management system and medical device regulatory requirements or with GMP environment, and in regulatory affairs is preferred
  • Experience in supervision of team
  • Systematic, driven, enthusiastic and resourceful with a “can-do” attitude
  • Must be capable of working as part of a team as well as working independently with minimal supervision 

About This Company

    Manufacturing - Non Electronics

Menicon Singapore Pte Ltd, a wholly owned subsidiary of Menicon Co. Ltd in Japan, and was established on 1st June 2007.  Menicon Singapore Pte Ltd is Menicon’s first contact lens manufacturing facility outside Japan. It produces daily disposable contact lenses, and is also the base for developing technologies and products with advanced, value-added features. We welcome dedicated and committed individuals who thrive on challenges and who dare to dream, to join our expanding team today!

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