Senior/Specialist QMS Engineer (MedTech)

Knowles Electronics · 📍 Canggu,Ubud,Denpasar,Jimbaran,Nusa Dua,Kuta,Badung · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
IDR 20000000 - 35000000
Knowles Electronics is seeking a highly skilled and experienced Senior/Specialist QMS Engineer (MedTech) to join our team. In this role, you will be responsible for ensuring the quality and compliance of our medical technology products. We offer a competitive salary, a dynamic work environment, and opportunities for professional growth. If you are passionate about quality management and have a strong background in MedTech, we encourage you to apply.

📋 Tanggung Jawab Pekerjaan

Develop, implement, and maintain Quality Management System (QMS) for MedTech products.,Ensure compliance with international quality standards and regulations.,Conduct risk assessments and implement corrective and preventive actions.,Lead quality improvement initiatives and projects.,Provide technical support and training to other team members.,Monitor and report on quality metrics and performance indicators.,Collaborate with cross-functional teams to ensure product quality and regulatory compliance.,Stay updated with the latest industry trends and best practices in QMS for MedTech.

🎓 Kualifikasi & Syarat

Bachelor's degree in Engineering, Quality Management, or related field.,Minimum of 5 years of experience in QMS for MedTech products.,Strong knowledge of ISO 13485, FDA, and other relevant quality standards.,Proven experience in risk management and quality improvement.,Excellent communication and interpersonal skills.,Proficiency in English (both written and spoken).,Experience with medical device software and hardware is a plus.,Certification in Quality Management or related field is a plus.

🛠️ Keahlian

Quality Management System (QMS)Risk ManagementRegulatory AffairsQuality ImprovementTechnical SupportProject ManagementData AnalysisTraining and Development
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