Manage all aspects of Quality Assurance functions related to Automotive / Medical Devices, both within the company & with customers to ensure that KPIs are met.
Identify gaps and risk of in operations against respective QMS and recommend improvement actions to management & lead the execution with management support.
Responsible to handle customer quality as key contact point focusing on customer specific requirements.
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Partner with R&D, Marketing, Regulatory Affairs, and Operations to support activities in product and process design such as design verification, design validation, design reviews, design transfer, and all other aspects of a design history file.
Create and maintain risk files consisting of but not limited to risk management plans, hazard and risk analyses, failure mode and effects analyses and risk management reports to assess the risks associated with a product.
Analyze post-market surveillance data periodically throughout a product’s lifecycle to feed back into it’s risk file in order to reflect it's current risk profile. Support Clinical and Medical Writers in the analysis of available clinical data, as required.
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Quality System Management (QA): Develop, implement, and maintain Standard Operating Procedures (SOPs), quality manuals, and Quality Management Systems (QMS) compliant with ISO standards (e.g., ISO 9001, ISO 13485).
Inspections & Testing (QC): Perform incoming material inspections, line checks, and final testing of finished goods or structural milestones prior to client approval or shipment release.
Audit & Compliance: Conduct scheduled internal quality audits, coordinate with external certification bodies, and ensure strict regulatory adherence across all operational processes.
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Test, diagnose, rework, and verify PSU sub-component and final electronic products of moderate to high complexity as prescribed by drawings, electrical schematics, and/or procedures.
Strong ability to Test and diagnose units with minimal direction.
Record failure data and test issues in databases as required. Work with Test engineers to document product repair changes. Evaluate results and recommend corrective action when required.
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Ensure all construction works comply with approved drawings, specifications, method statements, inspection and test plans (ITP), and relevant standards.
Conduct incoming material inspections and verify material approvals, certificates, and compliance before installation.
Carry out routine site inspections and quality surveillance throughout all construction stages.
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To update Standard Operating Procedures (SOP), Quality Management Policy, relevant systems and documents that related to ISO 22000, GMP, HACCP, HALAL and Food Safety Standards.
Monitor and maintain the company document control system.
Ensure manufacturing processes and procedures are meet the quality standard and regulation requirements.
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