Position Description

Quality Engineering Manager (Medical Device) / East
Job Code 20213
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
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Jobscope:

  • Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements.
  • Manage and supervise a team of ten or more direct reports who are focused on tactical, operational and some strategic activities within quality department.
  • Oversee Quality Engineering team functional roles, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports
  • Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of our products.
  • Participate on internal, inter-facility and vendors/suppliers quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
  • Drive the Manufacturing operations initiatives, qualification and validation activities for product or technology transfers.
  • Lead Quality improvement initiatives and align the organization to meet Quality goals and Objectives.

 

Requirements

  • Bachelors degree required with minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience in Pharmaceutical / Medical Device Manufacturing
  • Familiar with ISO 13485
  • Experience in managing a team size of 15-20 Engineers
  • Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
  • Preferably in a quality assurance or test related capacity.
  • Good written reporting skills and excellent English (oral and written reporting skills).
  • Able to multi-tasking and willing to take challenges.
  • Good communication skills to leverage multicultural and multi-departmental teams.

We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239

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