Medical Devices QMS ISO13485 Auditor

🕒 February 16

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BSI

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1901

📋 Compliance

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.

📋 Description

• As a RS Client Manager, you'll be responsible for frequently travelling and having overnight stays across South Korea. • You'll assess ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites. • Write up comprehensive reports and present these to the client. • Undertake extensive training to deliver in your role, including ISO13485 Lead Auditor course, MDSAP, and MDR. • Prepare assessment reports and deliver findings to clients. • Recommend the issue, re-issue or withdrawal of certificates. • Lead assessment teams and maintain quality of service.

🎯 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 and if you have JLPT N1 is a plus. • Animal tissue related medical device experience 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 • Good public speaking and business development skill will be considered advantageous.

🏖️ Benefits

• Professional development opportunities • Extensive training programs