BSI
Compliance • Healthcare • Sustainability
BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.
Medical Devices QMS ISO 13485 Auditor
November 14
🗣️🇰🇷 Korean Required
BSI
Compliance • Healthcare • Sustainability
BSI is a global Standards organization committed to helping organizations improve their performance and ensure safety, quality, and sustainability. As the UK National Standards Body, BSI provides a wide range of services, including certification, training, and assessment across various sectors such as healthcare, construction, and energy. BSI empowers businesses to adopt best practices and drive positive change through robust standards development and innovative solutions for a resilient digital future.
đź“‹ Description
• Responsible for assessing ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites • Write comprehensive reports and present to clients • Undertake management system assessments in accordance with BSI requirements • Prepare assessment reports and deliver findings to clients • Recommend the issue, re-issue or withdrawal of certificates • Lead assessment teams ensuring effective working relationships with clients and team members • Develop client partnerships to enhance business opportunities • Provide accurate and prompt information to support services • Plan/schedule workloads to maximize revenue-earning activity • Coach colleagues and assist in their induction
🎯 Requirements
• Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject • Minimum 5 years quality management and technology management working experience in the fields of Medical devices • Native Korean speaking, JLPT N1 is a plus • Commercial understanding of compliance industry, minimum 2 years quality system management • Knowledge of business processes and application of quality management standards • Good verbal and written communication skills and an eye for detail • Be self-motivated, flexible, and have excellent time management/planning skills • Can work under pressure • Willing to travel on business intensively • An enthusiastic and committed team player
🏖️ Benefits
• Comprehensive training • Opportunities for international travel • Supportive work environment • Professional development
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