QUALITY ASSURANCE MANAGER (1)(ARKRAY Industry, Inc.)

Job Description:

* Graduate of Bachelor of Science in Engineering or any related course, preferably chemical engineering or its equivalent; With at least 5 years of equivalent experience in manufacturing set-up specializing quality assurance.

Requirements

  • Graduate of Bachelor of Science in Engineering or any related course, preferably chemical engineering or its equivalent
  • With 5 years' experience in manufacturing set-up
  • Skills Required

  • With working knowledge in ISO 13485, FDA regulations and other local and international regulatory requirement.
  • Duties and Responsibilities

  • Responsible for RA activities including but not limited to product registration, compliance audits preparation and responding.
  • Accountable for compliance and recall issue and for carrying out investigation
  • Coordinate the on-time completion of CAPA documentation and activities
  • Oversee the compliance of document and data control systems
  • Manage the execution of internal and external audits and ensure timely closure of findings
  • Implement an effective operator training and certification program and manage the conduct of QMS trainings.
  • Drives to success of Teian (Kaizen) and TQC activities of the organization
  • Plan the compliance of the organization to Walmart, EMC, RoHs, WEE, REACH and other regulations the company needs to comply
  • Provide direction to shop-floor checks and other QMS activities of the organization
  • Office Location

      

    Lot 22 Phase 1A, First Philippine Industrial Park, Sta. Anastacia, Sto. Tomas, Batangas 4234