Process Quality Engineer/Senior Engineer

We are currently looking for a Process Quality Engineer/Senior Engineer for a leading player in the Medical Device Industry for their expansion. This company has a legacy of more than 100 years in the world. This position requires your urgent attention.

• Work mode: Hybrid (2days WFH; 3days WFO)
• US based company
• Based in Johor

the role

• Implement and refine manufacturing processes to improve efficiency, ensure compliance with industry standards, and reduce production costs and issues, ultimately enhancing overall operational performance.
• Oversee and ensure the thorough validation (IQ, OQ, PQ, PV) of critical manufacturing processes and equipment to consistently produce products that meet established quality standards.
• Support supplier process audits by ensuring effective process controls and verifying proper process qualification.
• Quickly identify and resolve quality issues by conducting root cause analysis and implementing corrective actions, minimizing downtime and preventing future occurrences.
• Lead continuous improvement initiatives focused on enhancing product quality, increasing process efficiency, and optimizing cost-effectiveness, contributing to long-term business success and innovation.
• Facilitate the smooth transition and integration of new processes.
• Recommend new tools that can automate tasks, improve data collection, or increase operational efficiency.

the experience

• Bachelor’s Degree in manufacturing engineering, quality management or any relevant discipline.
• Possess at least 2 years of experience in a process quality role in a medical device, EMS or any relevant industry.
• Proficiency in both Mandarin as this role requires to to serve a lot of Mandarin-speaking clients.
• Possess knowledge in quality management systems (ISO 13485, ISO 9001) and GMP regulations.