Senior QA Engineer (Quality Management System) - Medical Device Industry
Biobot Surgical Pte Ltd · 📍 Badung, Bali, Indonesia · Diposting 2026-10-09
FULL_TIME⭐ TERVERIFIKASI
USD 5500 - 7000
Biobot Surgical Pte Ltd is seeking a highly skilled Senior QA Engineer to join our team in Badung, Bali, Indonesia. In this role, you will be responsible for ensuring the quality and compliance of our medical devices, adhering to international standards and regulations. This is an exciting opportunity to work in a dynamic and innovative environment, contributing to the development of cutting-edge medical technologies.
As a Senior QA Engineer, you will play a crucial role in our Quality Management System (QMS), overseeing the quality assurance processes, and ensuring that our products meet the highest standards of safety and efficacy. You will work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive continuous improvement and innovation.
We offer a competitive salary of USD 5500 - 7000, along with a comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development and growth.
📋 Tanggung Jawab Pekerjaan
Tanggung Jawab:
Develop and implement quality assurance plans and procedures for medical devices.Conduct thorough testing and inspection of products to ensure compliance with international standards and regulations.Oversee the quality assurance processes, including risk management, process validation, and corrective and preventive actions.Lead and mentor junior QA team members, providing guidance and support to ensure the highest standards of quality.Collaborate with cross-functional teams to drive continuous improvement and innovation in our products and processes.Ensure compliance with regulatory requirements and industry best practices.Participate in regulatory submissions and audits, providing technical expertise and support.Stay up-to-date with the latest trends and developments in the medical device industry, and apply this knowledge to improve our products and processes.🎓 Kualifikasi & Syarat
Kualifikasi:
Bachelor's degree in Engineering, Quality Assurance, or a related field.Minimum of 5 years of experience in Quality Assurance for medical devices, with a strong understanding of ISO 13485 and other relevant international standards.Proven experience in leading QA teams and driving continuous improvement initiatives.Strong technical skills and knowledge of medical device technology and regulatory requirements.Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.Fluency in English, both written and spoken, is required.Knowledge of Bahasa Indonesia is a plus.Valid work permit for Indonesia is required.🛠️ Keahlian
<p>We are looking for a Senior QA Engineer who is passionate about qualityinnovationand compliance. If you have a strong background in Quality Assurance for medical devices and are eager to contribute to the development of cutting-edge technologieswe encourage you to apply. Join us in our mission to improve patient outcomes and make a positive impact on the healthcare industry.</p>
Lowongan Terkait