Quality Specialist
Hải Phòng
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TalentsAll's client is a European manufacturer specialized in developing, manufacturing, and supplying their premium power products with a range of customers worldwide in the medical, test & measurement, military, and robotics industries, and have been growing dynamically for over 30 years.
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JOB DESCRIPTION
- Maintain and improve the Quality Management System (QMS) and related procedures, work instructions and records.
- Coordinate the implementation and compliance with ISO 9001, ISO 13485 requirements.
- Plan and conduct Internal Audits; coordinate Certification, Customer and External Audits.
- Monitor audit findings, NC/CAPA, corrective actions and ensure timely closure and effectiveness.
- Manage quality-related documents and records in accordance with document control requirements.
- Coordinate risk assessment, quality objectives, KPI monitoring and continual improvement activities.
- Provide ISO/QMS awareness training and support departments in implementing system requirements.
- Prepare QMS reports and support Management Review activities.
- Monitor changes in applicable standards and regulatory requirements and ensure necessary actions are implemented.
- Perform other duties as requested by superiors.
ACTING AUTHORITY
- Request relevant departments to provide information and records required for QMS and audit activities.
- Propose changes and improvements to QMS procedures and related documents.
- Request and follow up corrective actions for identified non-conformities.
- Report serious risks and quality system non-compliance issues to management in a timely manner.
REQUIREMENTS
Education: Bachelor's degree in Engineering or related fields.
Experience
- Minimum 3 years of experience in Quality/QMS in a manufacturing company.
- Good knowledge and practical experience with ISO 9001, ISO 13485.
- Experience in ISO 14001 and ISO 45001 systems is an advantage.
- Experience in QMS implementation, Internal Audit, External/Customer Audit.
Languages
Good command of English.
IT Skills
- Proficient in MS Office.
- Experience with quality management systems or digital document management tools is an advantage.
Additional Skills
- Good analytical, problem-solving, communication and coordination skills.
- Proactive, responsible, systematic and able to work independently.
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