Process Improvement Specialist

6 days ago


Johor Bahru, Johor, Malaysia Refine Group Full time
Job Description

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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