ISO13485 Medical device auditor (Microbiology微生物背景优先)-remote

📋 Description

• • As a Remote ISO 13485 Medical Device Auditor with a preferred Microbiology background, you will play a pivotal role in ensuring the highest standards of quality and safety within the medical device industry. Your primary responsibility will be to conduct rigorous assessments of clients' quality management systems against the stringent requirements of ISO 13485, a globally recognized standard for medical devices. This role demands a deep understanding of medical device regulations, particularly the EU Medical Device Regulation (MDR) and the Medical Device Single Audit Programme (MDSAP), ensuring that clients are compliant and can confidently bring their products to market.
• • Your day-to-day activities will involve frequent travel to client sites across Taiwan, with the potential for overnight stays, to perform comprehensive audits. You will meticulously examine clients' processes, documentation, and adherence to quality management principles. Following each assessment, you will be tasked with preparing detailed and insightful reports that clearly articulate your findings. These reports will not only highlight areas of compliance but also identify any non-conformities and provide clear, actionable recommendations for corrective actions, ensuring clients understand the assessment decisions and have a clear path to improvement.
• • A significant aspect of this role involves presenting your assessment findings directly to clients. This requires excellent communication and interpersonal skills, enabling you to convey complex technical information in an understandable manner and foster a collaborative approach to problem-solving. You will act as a trusted advisor, helping clients to navigate the complexities of regulatory compliance and achieve excellence in their quality management systems.
• • BSI, the British Standards Institution, is a global leader in business improvement and standards. As part of our esteemed Regulatory Services team, you will contribute to our mission of ensuring patient safety and facilitating timely market access for medical device products worldwide. BSI holds significant designations, including being a Notified Body in the Netherlands, an accredited ISO 13485 Certification Body, and recognition in numerous global markets, underscoring the importance and impact of your work.
• • To equip you for success, BSI provides extensive training opportunities. This includes comprehensive courses on ISO 13485 Lead Auditing, MDSAP, and the EU MDR. This commitment to professional development ensures you are always at the forefront of regulatory knowledge and best practices, enabling you to deliver exceptional service.
• • Beyond client assessments, you will contribute to the growth and success of BSI. This involves establishing and nurturing effective partnerships with clients, understanding their evolving needs, and identifying opportunities for business development. By providing accurate and timely information to support teams and acting as a brand ambassador, you will help clients optimize their business performance and "Make Excellence a Habit."
• • You will also play a crucial role in coaching and mentoring colleagues, particularly those who are new to auditing or unfamiliar with specific client technologies. This collaborative approach ensures the consistent delivery of high-quality service across the team and supports the induction of new team members.
• • Maintaining and enhancing your own assessment skills and technical knowledge is paramount. You will stay abreast of the latest developments in quality management standards and medical device regulations, ensuring your expertise remains current and relevant. This continuous learning will enable you to provide valuable technical support to clients, business development, sales, and customer service staff.
• • The role requires a proactive and results-oriented mindset, with a strong emphasis on efficiency and the ability to manage your workload effectively to maximize revenue-earning activities. You will be expected to act ethically, adhere to company policies, and promote BSI services, helping clients achieve their business objectives.
• • Ultimately, your contributions will directly impact patient safety and the successful market entry of innovative medical devices. You will be instrumental in helping companies achieve compliance, improve their quality systems, and build trust in their products, thereby making a tangible difference in the healthcare landscape.