[Hiring] Medical Devices QMS ISO13485 Auditor @BSI

Role Description

As a RS Client Manager (Auditor) 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 the MDSAP scheme on customer sites, write up comprehensive reports, and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe.

You'll undertake extensive training to deliver in your role, which includes:

• ISO13485 Lead Auditor course
• MDSAP (Medical Device Single Audit Programme)
• MDR (Medical Device Regulation)

Qualifications

• Bachelor degree or above with a medical device industry related major or main professional qualification in a relevant subject
• Comprehensive knowledge of ISO 13485 and EU medical device regulation
• Minimum 5 years quality management and technology management working experience in the fields of Medical devices
• Native Korean speaking; JLPT N1 is a plus
• Experience in Active Medical Devices is highly preferred
• 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
• Self-motivated, flexible, and have excellent time management/planning skills
• Ability to work under pressure
• Willingness to travel on business intensively
• Enthusiastic and committed team player
• Good public speaking and business development skills will be considered advantageous

Requirements

• Undertake management system assessments in accordance with BSI requirements
• Prepare assessment reports and deliver findings to clients to ensure understanding of the assessment decision and clear direction for corrective actions
• Recommend the issue, re-issue, or withdrawal of certificates, and report recommendations in accordance with BSI policy
• Lead assessment teams as required, ensuring quality of service and effective working relationships
• Establish and develop effective partnerships to secure commercial relationships and encourage business development
• Provide accurate and prompt information to support services, ensuring client records are up to date
• Plan/schedule workloads to maximize revenue-earning activity
• Coach colleagues, especially inexperienced assessors or those unfamiliar with clients' business/technology
• Maintain and develop assessment skills and knowledge of technical and management system standards
• Provide technical support to clients through business development, sales, and customer service staff
• Act as a brand ambassador for BSI, promoting services to clients

Benefits

• Opportunity for extensive training and professional development
• Occasional international travel opportunities