Job 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

Job Requirement:

• Understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Strong problem-solving, organizational, analytical and critical thinking skills

• Understanding of processes and equipment used in assigned work

• Excellent documentation and communication skills and interpersonal relationship skills

• Expert understanding of manufacturing process/procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

• Experience writing and executing protocols for validation of tools, fixtures, equipment, and process.

• Ability to perform root cause analysis and recommendations. Capable of making decisions based on data, analysis, and problem-solving methods

• Knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, ISO14001)

• Strict attention to detail

• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

• 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.

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

• Prior medical device experience is preferred

Job Type: Contract
Contract length: 12 months Salary: RM7,000.00 - RM9,000.00 per month Experience:

• Quality management: 5 years (Preferred)
• ISO: 2 years (Preferred)