Quality Engineer

Owen Mumford Sdn Bhd
Full Time
Application deadline closed.

Job Description

Job Scope:

  • Monitoring and upholding Current Good Manufacturing Practices (cGMP) requirement to the manufacturing process in line with the recommendations for medical devices.
  • To ensure implementation of, and adherence to, GMP throughout the company.
  • The records of product batch release and Device History Records.
  • The release of finished goods.
  • The product bioburden and sterility requirement.

Key Responsibilities:

  • Coordinating new/ revised packaging materials/ components/ label approval process, ensuring the process complies to the change control requirement.
  • Review and approve qualification/ validation protocols and qualification/validation reports for tools, equipment, facilities, utilities, test methods and computerised systems.
  • Evaluate local quality-related suppliers, monitor the supplier performance and provide feedback to the Quality Manager.
  • Administrating quality audit activities to ensure compliance with procedure.
  • Review Device History Record for Medical Devices and components manufactured by Owen Mumford.
  • Coordinating microbiological monitoring of the environmental and products. As well as trending of the results.
  • Performing continuous Quality Control evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with local SME as required.
  • Working with SME’s to assist investigation and close out of any Exceptions and related Investigations and Corrective and Preventive Actions (CAPAs).
  • Reporting to Quality Manager on progress with activities, provision of metrics and other information (e.g. input to Weekly /Monthly Quality Reports and Management Review Meeting) and escalation of issues.
  • Complying with Owen Mumford policies and procedures and fulfil roles and responsibilities as defined to support full compliance.
  • Identifying areas for improvement in daily work.
  • Completing work to agreed priorities and meet due dates. Report to those in authority if any timelines are likely to be missed.
  • Listening to performance feedback provided and take any necessary improvement action.
  • Completing personal Training and Development Plan and seek opportunities to grow and learn.
  • To be appointed as an Internal Quality Auditor upon qualified.

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