Fong’s Engineering and Manufacturing Pte Ltd · 2 days ago

Senior Quality Engineer

Irvine, CA

Full-time

Onsite

Senior Level

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Industrial ManufacturingMachinery Manufacturing

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Responsibilities

Act as the Quality Leader and report to Singapore HQ for all Quality matters for ISC.

Ensure ISC compliance with local, state, and federal regulations, and obtain necessary certifications and approvals from regulatory bodies including FDA and ISO.

Develop and implement a robust QMS for ISC by working closely with Singapore HQ.

Prepare plan for GxP software implementation together with Service Operations team for proposal to top management.

Strategize and develop a sustainable model for execution of quality event reporting for internal and external stakeholders.

Work closely with Service Operations, Customer Service team to co-develop an efficient process flow for servicing medical equipment returns.

Handle customer complaints, investigations.

Lead and drive all validation activities during the setup phase of the ISC.

Establish, develop and document Quality SOPs and WI for all service center operations.

Lead and prepare Irvine team for internal and external audits.

Oversee daily tasks related to Quality operations.

Perform other ad-hoc duties as assigned by immediate supervisor.

Qualification

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ISO 13485FDA QSRValidationLead Internal AuditorQMS Setting UpQMS MaintenanceProblem-SolvingTime ManagementAttention to DetailEfficiency Drive Understanding