QA Senior Manager

Requirements

Candidate must possess at least Degree in Engineering

Worked in an electronics manufacturing industry with managerial position for at least 10 years and above

Well participated in Management System implementation, New Product Qualification and maintenance

Experience in plan, conduct / handle and follow up on 1st, 2nd & 3rd parties audits

Familiar & good in practices of ISO9001 / ISO14001 / ISO13485 / RBA / IATF16949 / ESD S20.20

Familiar with good in handling practices of RoHS, REACH, Conflict Mineral, Product Safety (UL)

Well practised in 7 QC Tools, 8D, 5 Core Tools, Capabilities studies, DMAIC

Experienced in Calibration Management on ISO9001 standard requirement as minimum; with ISO17025 standards requirement will be an advantage

Possess System, Process based and Product auditing skills & experiences

Good in Leadership, communication & presentation skills

Work independently and ability to co-ordinate team to accomplish the assigned project

Job Descriptions

Responsible for leading the Quality Department and acting as the organization's QMR

Drive QMS activities throughout company to ensures that the Quality Management System (QMS) is effectively implemented, maintained and improved to meet applicable standards, customer requirements and regulatory compliance

Establish and enforce quality policies, SOPs, and quality plan

Ensure Company policy / objectives / targets are aligned with business strategy & direction

To identify risks and opportunity of context, customer requirements and interested parties for Quality division

Monitor and maintain quality KPIs

Report to top management on QMS performance and opportunities for improvement

Promote awareness of customer and regulatory requirements throughout the organization

Lead internal and external audits, management reviews, and compliance actions

Maintain documentation control and change management per QMS requirements

Maintain company certifications and ensure compliance with regulatory bodies (e.g. ISO 9001, ISO 13485, etc.)

Prepare documentation for customer and third-party audits

Oversee QA / QC department performance and ensure work smoothly

Lead and manage the QA / QC teams, including training, development, and performance evaluation

Drive CAPA, 8D, and root cause analysis processes

Review and approve quality records (e.g. CoC, batch records, test reports)

Lead risk assessments and improvement initiatives

To ensure availability and adequacy of required resources to maintain and continually improve management system

To establish and drive motivation program (RCA) to employees for continual improvement activities

To ensure customer satisfy with Overall Quality Performance

To perform any tasks as assigned by superior

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