Process Improvement Specialist
6 days ago
We are seeking a highly skilled Process Quality Engineer/Senior Engineer to join Refine Group, a leading player in the Medical Device Industry.
- This is a US based company with operations in Johor.
The Role:
- Develop and refine manufacturing processes to enhance operational performance, ensure compliance with industry standards, and reduce production costs and issues.
- Validate critical manufacturing processes and equipment through thorough qualification (IQ, OQ, PQ, PV) to consistently meet established quality standards.
- Collaborate with suppliers to ensure effective process controls and verification of proper process qualification.
- Analyze quality issues, implement corrective actions, and minimize downtime to prevent future occurrences.
- Lead initiatives focused on enhancing product quality, increasing process efficiency, and optimizing cost-effectiveness.
- Facilitate smooth transitions and integration of new processes.
- Recommend tools to automate tasks, improve data collection, or increase operational efficiency.
Requirements:
- Bachelor's Degree in manufacturing engineering, quality management, or relevant discipline.
- At least 2 years of experience in a process quality role in a medical device, EMS, or relevant industry.
- Proficiency in Mandarin, serving clients in this language.
- Familiarity with quality management systems (ISO 13485, ISO 9001) and GMP regulations.
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