Quality Engineer (Medical Device Industry)

Location: Oasis Square, Ara Damansara, Petaling Jaya, Selangor Working Days/Hours: Monday – Friday, 8:00 AM – 5:00 PM Contract Duration: 12 months (with PERSOLKELLY) Salary: RM7,000 to RM9,000 (based on experience & skills) + statutory contributions + leave entitlement + medical coverage JOB SUMMARY We are currently seeking a highly skilled and experienced individual to join our team as a Quality Engineer. In this role, the successful candidate will play a crucial role in ensuring product quality assurance support for Medical Products and management of quality system to meet Malaysia MDA requirements The ideal candidate for this position will have a strong background in quality engineering within the Medical Products with a deep understanding of ISO 13485 requirements, GDPMD reguirements, Malaysian Medical Device and Cosmetic regulations. They should possess excellent communication and leadership skills, with the ability to collaborate effectively with cross-functional teams. Strong analytical and problem-solving abilities, along with a commitment to continuous improvement, are also essential. YOUR RESPONSIBILITIES • Enhancing Customer Satisfaction – Implement quality activities aligned with division quality strategy to enhance customer satisfaction. • Quality System Leadership – Establish and maintain the quality management system in Korea for Medical Device and Cosmetics. • Leading Quality Qualification in New Product and Product Change Projects - Ensure new or modified products to meet customer, regulatory, marketing requirements. • Resolving Quality Issue – Lead the communication between lab and plant to minimize the lead time to resolve the issue and complaint sample analysis. • Supplier Product Quality Management – Establish supplier product quality plans to ensure the outsourced product to meet its requirements. • Product quality – Support product quality such as design issue follow-up, sampling plan revisit for product release, document revision, etc. WHO CAN APPLY? • Bachelor’s degree or higher in a Science, Technology, Engineering or Mathematics (STEM) or related discipline from an accredited university • 5 years of Experience in Medical Device industry • 3 years of combined experience in a Manufacturing, Production, Quality and/or Laboratory role in a private, public, government or military environment • Experience in Medical Device QMS – ISO 13485, MSAP, MDD, Malaysia MDA regulations • Certifications in quality engineering, quality auditing or quality management according EOQ standard or comparable • Microsoft Office proficient How to Apply? Send your resume to [email protected] (Only shortlisted candidates will be contacted.)