Senior QA Engineer (ISO 13485) - Medical Device & MedTech Industry

RecruitPedia Pte Ltd · 📍 Badung, Bali, Indonesia · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
USD 4000 - 5300
RecruitPedia Pte Ltd is seeking a highly skilled Senior QA Engineer to join our team in Badung, Bali. This role is crucial for ensuring the quality and compliance of medical devices and MedTech products. The ideal candidate will have a strong background in ISO 13485 standards and a passion for improving product quality. This is an exciting opportunity to work in a dynamic and innovative environment.

📋 Tanggung Jawab Pekerjaan

Lead and manage the quality assurance process for medical devices and MedTech products.,Ensure compliance with ISO 13485 standards and other relevant regulations.,Develop and implement quality assurance plans and procedures.,Conduct testing and validation of medical devices to ensure they meet safety and performance requirements.,Identify and resolve quality issues and defects in products.,Collaborate with cross-functional teams to improve product quality and compliance.,Ensure all quality records and documentation are accurate and up-to-date.,Provide training and support to junior QA engineers and other team members.

🎓 Kualifikasi & Syarat

Bachelor's degree in Quality Assurance, Engineering, or a related field.,Minimum of 5 years of experience in Quality Assurance for medical devices or MedTech products.,Certification in ISO 13485 is a plus.,Strong knowledge of quality management systems and standards.,Experience with medical device testing and validation processes.,Proficient in using quality assurance software and tools.,Excellent analytical and problem-solving skills.,Strong communication and teamwork skills.

🛠️ Keahlian

ISO 13485 standardsQuality management systemsMedical device testing and validationQuality assurance softwareAnalytical and problem-solving skillsCommunication and teamwork skills
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