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Smoothmoves, Inc. is seeking an experienced Quality Assurance professional to manage the QMS and ensure ISO 9001 compliance across production and materials. You will lead root-cause analyses (8D/QRQC) with EMPI teams, validate products and processes, and drive continuous quality improvements.
The role requires a B.S. in Engineering or Science, at least 5 years in QA, knowledge of SPC and FMEA, ISO training, and strong English communication. On-site in Makati, Philippines.
On-site - Makati 5-10 Yrs Exp Bachelor Full-time
Job Description
Performance Bonus, Anniversary Gifts, Annual Appraisal, Holiday Gifts
Bereavement Leave, Birthday Leave, Maternity & Paternity Leave, Sick Leave, Vacation Leave
Flexible Hours
Main responsibilities:
Ensures the organization's processes, products, and systems comply with applicable industry standards like ISO 9001, as well as relevant legal and regulatory mandates.
Creating and maintaining a Quality Management System (QMS) that supports continuous improvement, operational efficiency, and the long-term success of the organization.
Implementing quality standards and ensuring products consistently meet specifications.
Develops autonomy and supports EMPI departments (Production, Methods, CI, Maintenance ...) in order to properly conduct root cause analysis as well as all methodology of problem solving and action plan implementation (8D, QRQC...)
Actively participates in the qualification and validation of products and raw materials, production machines and IMTE for production use.
Ensures the calibration of all inspectors in accordance with the central quality requirements.
Assesses product specifications of the company meet customer requirements.
Oversees 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 respect to FDA (Food and Drug Administration) requirements (CMDN certification)
Main requirements:
B.S. Engineering or Scientific degree
With adept knowledge in Quality Assurance concepts such as: total Quality Management, Problem solving techniques, Statistical Process Control (SPC) & Quality Tools (8D, FTA, Ishikawa Diagram), Risk Assessment, and FMEA.
With at least 5 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
HR Manager Smoothmoves, Inc.