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QARA Manager

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QARA Manager

  • Location:


  • Sector:

    Monroe Hospital & Healthcare

  • Job type:


  • Salary:


  • Contact:

    Gwen Hong

  • Contact email:

  • Job ref:


  • Published:

    22 days ago

  • Expiry date:


​​​​​​Executive recruitment company Monroe Consulting Group Malaysia's Healthcare Division is partnered with a multinational medical device company. We are looking for a Quality System Specialist to maintain and improve the global quality system processes include Document Control, Change Control, Design Controls, Complaints, CAPA, Quality Non-Conformance process, Deviations, Supplier Management, Training Programs, eQMS Systems, Audits programs, and related sub-systems.

The opportunity is based in Malaysia with remote-work arrangement.

Job Responsibilities:

  • Assists the quality system's administrative tasks, such as rerouting, reassigning, and amending eQMS records in accordance with procedures.
  • Maintains global operating policies and procedures to ensure compliance to regulations / procedures and to drive business results.
  • Establishes and integrates quality system processes with other quality systems and subsystems.
  • Implements measures to monitor the effectiveness of quality system processes and drives improvement.
  • Manages KPIs for applicable Quality System processes.
  • Monitors applicable records to ensure targets (e.g. timeliness, quality, etc.) for records are met.
  • Participates as a key member in both external and internal audits throughout the global organization.
  • Creates and provides ongoing quality system element process and system training.
  • Administers quality system processes, including approving extensions, reviewing investigations, conducting training and reporting KPI's.
  • Facilitates the Review Board for applicable quality system processes, ensuring that significant and recurring issues are escalated to Management.
  • Performs other work-related duties, as assigned by management.

Job Requirements:

  • Bachelor's degree preferably Engineering or Science, is required.
  • A minimum of 5 years of experience is required in Quality Systems, Regulatory, or Quality Assurance in medical devices/pharmaceutical or a related field with 3 years of demonstrated leadership capability.
  • Demonstrated ability to influence, organize and motivate cross-functional teams at all levels in the organization to meet quality and compliance goals.
  • Knowledge of regulatory requirements (FDA, ISO, EU MDD/ EU MDR, Canadian MDR, Japan PAL) and experience with external auditing bodies medical device auditing experience.
  • Experience working with a global team.
  • Ability to prioritize, direct, and manage multiple projects consisting of varying degrees of complexity.
  • American Society for Quality or similar professional certification- preferred.
  • Experience with medical devices company- preferred.
  • Experience with the use of Statistical techniques and tools- preferred