BSI is seeking an ISO13485 Medical Device Auditor to conduct on-site assessments of quality management systems in accordance with ISO 13485, EU Medical Device Regulations, and MDSAP standards across Taiwan, with occasional international travel to the USA and Europe. As a key representative of BSI, you will act as a brand ambassador, delivering client-focused services while ensuring compliance and excellence in medical device manufacturing.
What You'll Do
- Undertake management system assessments in accordance with BSI requirements.
- Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate.
- Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame.
- Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team.
- Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio.
- Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met.
- Plan/schedule workloads to make best use of own time and maximise revenue-earning activity.
- Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested.
- 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. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”.
What We're Looking For
- Bachelor degree or above with 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
- Hands-on experience of working as a microbiologist in the manufacture of sterile products
- Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body
- Active medical device or active implantable device
- 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
- Conceptual and analytical thinking, efficiency and focus on results
- A team player, good at relationship building internally and externally
- Broad technical understanding of clients, medical device industry and sterile products
- 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
- Taiwan local hire
Nice to Have
- Good public speaking and business development skill
Technical Stack
- ISO 13485
- MDSAP (Medical Device Single Audit Programme)
- MDR (Medical Device Regulation)
- EU medical device regulations
Team & Environment
- Regulatory Services team
Benefits & Compensation
- Extensive training including ISO13485 Lead Auditor course, MDSAP, and MDR
- Opportunity for occasional international travel to the USA and Europe
- Act as a brand ambassador for BSI
- Work with a global community of experts, industry and consumer groups, organizations and governments
- Participate in tackling society’s critical issues such as climate change and digital transformation trust
Work Mode
- Frequent travel and overnight stays across Taiwan required; occasional international travel to USA and Europe
BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.
