[Hiring] ISO13485 Medical device auditor @BSI

Role Description

As a Medical Devices QMS Auditor, you'll be responsible for frequently travelling and having overnight stays across Taiwan. You'll assess ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites, write comprehensive reports, and present these to clients. You'll also have opportunities for occasional international travel to the USA and Europe.

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

• 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
• Sterile implantable device background will be highly preferred
• Thorough knowledge of Medical Device regulation
• Concepts and intent of product certification and service delivery
• Knowledge of business processes and the application of quality management standards
• Good verbal and written communication skills and an eye for detail
• Self-motivated, flexible, and excellent time management/planning skills
• Ability to work under pressure
• Willingness to travel on business intensively
• Good public speaking and business development skills will be considered advantageous

Requirements

• Conceptual and analytical thinking, efficiency, and focus on results
• Team player, good at relationship building internally and externally
• Broad technical understanding of clients, medical device industry, and sterile products
• Ability to coach colleagues, especially inexperienced assessors
• Maintain and develop assessment skills and technical and management system standards knowledge
• Provide technical support to clients through business development, sales, and customer service staff
• Act as a brand ambassador for BSI, promoting services to optimize business performance

Benefits

• Delivery of man-days as booked in time and good quality work with positive feedback from clients
• Efficient feedback to both clients and internal queries
• Timely submission of reports
• Actively solve problems with a “can do” attitude
• Add value to clients by identifying their needs and introducing multiple BSI services
• Help avoid customer attrition by providing quality value-added service and technical support