Quality Assurance Leader: QMS, ISO & Regulatory Compliance

Aickman & Greene

Mariveles

On-site

PHP 600,000 - 900,000

Full time

7 days ago

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Job summary

Aickman & Greene seeks a senior Quality Assurance professional in the Philippines to lead the QMS, ensure products meet specifications, and drive continuous improvement across operations. You will support Production, Methods, CI, and Maintenance in root-cause analysis, participate in qualification/validation of products and materials, and ensure inspector calibration to central quality requirements.

English fluency, ISO knowledge, and experience in multinational contexts (Japanese company

Qualifications

B.S. Engineering or Scientific degree required.
Adept knowledge in Quality Assurance concepts such as: total Quality Management, Problemsolving techniques, Statistical Process Control (SPC) & Quality Tools (8D, FTA, Ishikawa Diagram).
Risk Assessment, and FMEA.
With at least 5-10 years of experience.
Working knowledge on ISO standards; ISO training Certification, Calibration Standards Training.
Certification, basic ISO system- Management of Change, Risk Assessment, Customer Complaint & CAPA.
With DPO Certification.
With knowledge on Medical Regulatory requirements.
Fluency in English language is a must.
With strong drive, skills to influence others.
Preferred from Multinational Company
Come from Japanese Company is a advantange

Responsibilities

Create and maintain a Quality Management System (QMS) that supports continuous improvement, operational efficiency, and long-term success of the organization.
Implement quality standards and ensure products consistently meet specifications.
Develop autonomy and support EMPI departments (Production, Methods, CI, Maintenance) in root cause analysis and problem solving.
Actively participate in qualification and validation of products and raw materials, production machines and IMTE for production use.
Ensure the calibration of all inspectors in accordance with central quality requirements.
Assess product specifications to ensure they meet customer requirements.
Oversee processes to ensure they are efficient, robust, and capable of consistently producing high-quality products and services by driving process capability improvement.
Ensure EMPI product compliance with FDA requirements (CMDN certification).