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Process Quality Engineer Medical Device

2 months ago

Ipoh, Perak, Malaysia Randstad Malaysia Full time

We are currently looking for a Process Quality Engineerfor 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)Based in Perak 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 or EMS 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.
skills no additional skills required
qualifications no additional qualifications required
education Bachelor Degree