Equipment & Software Quality Engineer - Medical Devices

Join Boston Scientific, a global leader in medical technology, as an Equipment & Software Quality Engineer in our dynamic team based in Badung, Bali. In this pivotal role, you will drive Non-Device Software Qualification initiatives, ensuring the highest standards of quality and compliance in our medical devices. With a strong focus on innovation and patient safety, Boston Scientific offers a unique opportunity to contribute to cutting-edge medical technology.

As an Equipment & Software Quality Engineer, you will be responsible for developing and implementing quality assurance processes for non-device software. You will work closely with cross-functional teams to ensure that our software meets regulatory requirements and industry standards. This role offers a dynamic and challenging environment where you can make a significant impact on the quality and safety of medical devices.

In Badung, Bali, you will enjoy a vibrant and supportive work environment, with access to world-class medical technology and a team of dedicated professionals. This is your chance to be part of a global company that values innovation, excellence, and the well-being of patients.

📋 Tanggung Jawab Pekerjaan

• Develop and implement quality assurance processes for non-device software
• Ensure compliance with regulatory requirements and industry standards
• Conduct software testing and validation to guarantee quality and performance
• Collaborate with cross-functional teams to identify and resolve quality issues
• Monitor and report on quality metrics and trends
• Participate in continuous improvement initiatives to enhance quality processes
• Provide technical support and guidance to internal teams
• Stay updated with the latest advancements in medical technology and quality assurance practices

🎓 Kualifikasi & Syarat

• Bachelor's degree in Computer Science, Software Engineering, or a related field
• Minimum of 5 years of experience in software quality assurance, with a focus on medical devices
• Certification in quality assurance, such as Certified Software Quality Engineer (CSQE) or Certified Medical Device Quality Engineer (CMQE)
• Strong knowledge of quality management systems, including ISO 13485
• Proficiency in software testing tools, such as JIRA, TestRail, or similar
• Experience with medical device regulations, such as FDA 21 CFR Part 820 or IEC 62304
• Excellent communication and interpersonal skills
• Ability to work in a fast-paced, dynamic environment

🛠️ Keahlian

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