Role OverviewWe are looking for a skilled ISO 13485 Medical Device Auditor with a background in microbiology to lead remote and on-site assessments across Taiwan, with occasional international assignments. You will evaluate quality management systems for compliance with ISO 13485, EU MDR, and MDSAP requirements, delivering clear, actionable findings to clients.
Key Responsibilities
- Conduct thorough assessments of management systems in line with organizational standards
- Prepare detailed audit reports and communicate outcomes effectively to clients
- Recommend certification decisions and ensure timely reporting in accordance with internal policies
- Lead audit teams, ensuring proper briefing and consistent service quality
- Build strong client relationships that support long-term engagement and service expansion
- Support internal teams with accurate, up-to-date client information and records
- Manage your schedule efficiently to maximize productivity and revenue-generating activities
- Mentor junior auditors and assist in onboarding new team members
- Continuously develop technical and auditing expertise
- Provide technical guidance to sales and customer service teams during business development
- Represent the organization ethically and professionally, promoting best practices and service excellence
Qualifications and Experience
- Degree in a relevant field such as life sciences, medical technology, or a related discipline
- In-depth understanding of ISO 13485, EU MDR, and MDSAP frameworks
- Minimum of five years in quality or technical management within the medical device sector
- Hands-on experience as a microbiologist in sterile product manufacturing
- Experience with medical devices involving biological coatings, absorption, or local dispersion in the body
- Familiarity with active and implantable medical devices
- Solid grasp of certification processes and quality management principles
- Strong analytical abilities and results-oriented mindset
- Excellent interpersonal and communication skills
- Proven ability to work independently and under pressure
- Highly organized with strong planning and time management capabilities
- Willingness to travel frequently within Taiwan and occasionally internationally
- Local candidate based in Taiwan
Preferred Attributes
- Experience in public speaking or business development is a plus
Training and Development
You will receive comprehensive training in ISO 13485 Lead Auditing, MDSAP, and MDR to ensure you are fully equipped for your role. This position offers opportunities for professional growth and international exposure, including travel to the USA and Europe.
Work Environment
This is a hybrid role with remote work flexibility. However, frequent travel and overnight stays across Taiwan are required. Occasional international travel may also be necessary.
Organizational Values
Our culture emphasizes ethical conduct, continuous improvement, and client-focused service delivery. We aim to support positive change in the industry and promote sustainable business practices. As a representative of the organization, you will help clients adopt a mindset of consistent excellence.
