Document Coordinator, Quality Operations

1 week ago

Gelang Patah, Johor, Malaysia Insulet Full time 30,000 - 60,000 per year

Position Overview:

The Document Coordinator, Quality Operations is responsible for all aspects of Quality Operations Device History Record (DHR) and Quality Records administration. All work to be done in accordance with complying Insulet's defined Standard Operating Procedures, Work Instructions and Health & Safety requirements at all times.

Responsibilities:

  • Responsible for executing lot release of finished product, including review and completing record / checklist required for lot release.
  • Take lead in ensuring effective movement of DHR file through Production and Quality to ensure a timely delivery of completed accurate file for the Medical Device DHR.
  • Review completed DHR for completeness, accuracy and GDP.
  • Maintain inspection records and ensure data entered the computer and/or MES/SAP system.
  • Responsible for the identification, storage, security and integrity, retrieval, retention, and disposition of the DHR records and retained samples.
  • Assist in activities that contribute to upholding high standards of DHR and Quality Records.
  • Responsible for improving and providing effective review of the documentation review process.
  • Support in Quality Operations related administrative activities as required.
  • Provide training as necessary to fulfill the responsibilities of the role.
  • Participate in continuous improvement into the investigational process to yield more efficient and robust processes.
  • Preparing daily, weekly and monthly reports of lot release & quality inspection testing.
  • Assist Quality Engineers in handling CAPA, NCMR and MRB.
  • Participate in internal or external quality audits, as required.
  • Performs other duties as required.

Requirements

  • Minimum Diploma in Engineering or Science, or with a combination of education and experience.
  • 1 to 3 years of hands-on experience in quality operation, inspection and testing, preferably in the medical device industry.
  • Reasonable understanding of ISO13485, GMP and GDP requirements.
  • Experience in GDP (Good Documentation Practices) & legible handwriting.
  • Microsoft Excel, data entry and analytical skills.
  • Must be proficient in both English and Malay language.
  • Team player and ability to communicate effectively with supervisor and other employees.

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