Job Description

Job Description

  • Manage, lead and execute quality system management documentation base on ISO 9001:2008, ISO 13485: 2012, 510k regulation, MDD anex II.3 and good storage
  • Manage, lead and execute implementation of all requirements and regulation from RI MOH, FDA (510k), Japan regulation, MDD regulation
  • Manage, lead and execute of quality assurance matter (quality audits (internal & external), change control, validation)
  • Prepare and executed all validation studies (environmental, machine, packaging, sterilization process)
  • Manage and lead domestic and overseas regulatory activity (production license & product license)
  • Manage handling customer complains, FDA complains
  • Manage and preparing risk analysis, grouping establishment of acceptance criteria, sampling plan/procedure
  • Lead pre-initial assessment and review proposed change in relevance to validation activities feedback
  • Assure compliance of purchasing of raw material, packaging standard and other component related to manufacturing activities
  • Act as lead auditor for internal and external audit or three partied
  • To ensure that testing of packaging material, raw material and finish good are performed according to current specification and method and incomplaint with NIPRO group quality standard
  • Handling out of specification within laboratory


Job Requirement

  • M/F maximum 45 years old
  • Education Min from medical/pharmacy or related major
  • Having experience implement ISO 13485 
  • Having experience as QA/QC Asst Mgr/Manager in pharmaceutical/medical device industry
  • Able to speak English fluently (can speak Japanese is an advantage)
  • Have experience with FDA/510k registration (is an advantage)
  • Willing to work in East Karawang, West Java 


This vacancy is on behalf of our client.