Quality Engineer

About the role

As a Quality Engineer at Hochuen Medical Sdn Bhd, you will play a crucial role in ensuring the highest standards of quality and compliance for our medical products. Reporting to the Quality Assurance Manager, you will be responsible for implementing and maintaining robust quality control processes across our manufacturing facilities in Senai, Johor. This full-time position is an excellent opportunity for an experienced quality professional to make a direct impact on the success of our growing company.

What you'll be doing

• Ensure quality of product meet customer specification and fitness for use
• Prepare relevant quality report for management review
• Responsible for customer's quality feedback and timely response as well as new/revised requirement
• Work with production / sales department on quality issues and customer feedback.
• Process SPC monitor and continual improvement to meet customer needs and satisfaction
• Coordinate, lead and guide the matter of process discrepancy and product non-conformity
• Manage all quality-related issues within the manufacturing team (e.g. internal, supplier, customer and customer warranty)
• To identify root cause and instigate permanent corrective actions (8D) for product quality issues.
• Customer return material authorization (RMA) verification.
• To resolve all quality issues or irregular problem feedback by QA Inspectors/Production Operators
• Continues work with supplier to improve process control to meet internal and customer requirements
• Able to prepare relative product’s SIP or MSOP and training QC for SIP or MSOP
• Perform any other task as assigned by superior

What we're looking for

• Bachelor's degree in Engineering, Quality Management or a related technical discipline
• Minimum 5 years of experience in a quality engineering or quality assurance role, preferably in the medical device or pharmaceutical manufacturing industry
• Proven track record of implementing and optimising quality control systems and processes
• Excellent problem-solving, analytical and decision-making skills
• Strong technical knowledge of quality management tools and methodologies (e.g. SPC, FMEA, Six Sigma)
• Proficient in data analysis and reporting using relevant software tools
• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams
• Knowledge of relevant quality standards and regulations (e.g. ISO 13485, GMP)

What we offer

• Competitive salary and performance-based bonuses
• Comprehensive health and life insurance coverage
• Generous paid time off and flexible work arrangements
• Opportunities for professional development and career advancement
• Supportive and collaborative work environment

About us

Hochuen Medical Sdn Bhd is a leading manufacturer of high-quality medical devices, serving healthcare providers and patients worldwide. With a strong focus on innovation and quality, we are committed to improving patient outcomes and enhancing the delivery of healthcare services. Our state-of-the-art production facilities in Senai, Johor are equipped with the latest technology and staffed by a dedicated team of professionals. We foster a culture of continuous improvement, collaboration and employee well-being, making Hochuen Medical an excellent place to build a rewarding career.
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