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
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.