job description
Join Brosmed Medical (Malaysia) Sdn Bhd, a leading innovator in medical device manufacturing, as our QA Engineer based in Bali, Indonesia. In this critical role, you will ensure the highest standards of quality and compliance for our cutting-edge medical devices, contributing to life-saving technologies that make a global impact.
As a remote QA Engineer, you will collaborate with cross-functional teams across Asia, leveraging digital tools to maintain rigorous quality assurance processes. This position offers the flexibility of remote work while providing opportunities to grow your expertise in medical device regulations (ISO 13485, FDA 21 CFR Part 820) and advance your career in a dynamic, fast-paced industry.
We value professionals who are detail-oriented, proactive, and passionate about improving healthcare outcomes. If you thrive in a collaborative environment and want to work with a company that prioritizes quality and innovation, we invite you to apply and become part of our mission to deliver safe and effective medical solutions worldwide.
Responsibility
- Develop, implement, and maintain quality assurance procedures and documentation for medical device manufacturing processes.
- Conduct risk assessments and ensure compliance with international medical device regulations (ISO 13485, FDA 21 CFR Part 820, EU MDR).
- Perform internal audits and coordinate external audits to verify adherence to quality standards.
- Investigate and resolve quality issues, non-conformances, and customer complaints using root cause analysis (RCA) techniques.
- Collaborate with R&D, production, and supply chain teams to ensure product quality from design to distribution.
- Monitor and analyze quality metrics, generating reports for management review and continuous improvement initiatives.
- Support validation activities for manufacturing processes, equipment, and software systems.
- Provide training to staff on quality procedures, regulatory requirements, and best practices.
Qualifications
- Bachelor’s degree in Biomedical Engineering, Quality Assurance, or a related field.
- Minimum 3 years of experience in QA roles within the medical device or pharmaceutical industry.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
- Experience with risk management (ISO 14971) and quality management systems (QMS).
- Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone Diagram, FMEA).
- Excellent attention to detail and problem-solving skills with a proactive mindset.
- Strong communication skills in English (written and verbal) for collaboration with international teams.
- Certification in quality assurance (e.g., CQA, CQE) or regulatory affairs (e.g., RAC) is a plus.