Job Description

Description

• Assess technical service center quality and compliance level. provide recommendations and drive appropriate actions including but not limited to, escalation through the Non-conformance, CAPA and PRA processes
• Review and approve the Validation Plan/documentation as Quality Engineer. Approver of Calibration/ Maintenance plan in Maximo as SQE. Change leader of Trouble Shooting RBM
• Assess the readiness of facility, processes, and people qualification from quality compliance for new product launch
• Partner with FCA coordinator to execute FCA related to TSC
• Support the tech service team in the identification, development and execution of continuous improvement projects ensuring global standardization and compliance
• Manage technical service project quality activities with the accountability for successful completion of all deliverables to the business within established schedule, scope and quality objectives.
• Partner with cross functional groups to identify risks, develop mitigation strategies, alternative solutions, resolve issues, action item follow up
• Supplier File Management SQMS/EQMS, Supplier Review Board, Supplier Audit coordinator for APAC
• Internal audit coordinator, File management, trending, tracking of audits and its related action plans

Requirements :

• Bachelor\'s Degree in Engineering
• At least 6 years experiences in healthcare industry
• Understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, ISO14001)
• Communications ability in English for presentations, written documents, and verbal. The ability to communicate to senior management, peer levels, and subordinate levels of the organization in a clear, concise, and accurate manner.

Industry

Healthcare

Specialization

Engineering

Location

Kuala Lumpur

Employment Type

Contract / Temp

Salary

MYR 8, 001 - MYR 10, 000 / mth

To apply online please click the \'Apply\' button below. For email a detailed resume in Word format to Amanda Loo.

For further discussion about this role, please find contact details of Amanda Loo as below:
Email: amanda.loo@recruitexpress.com.my
Tel: 0327138830
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

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