Join a globally recognized organization in standards and regulatory compliance as an ISO13485 Medical Device Auditor with a specialization in microbiology. You will conduct third-party assessments for medical device manufacturers across Taiwan, with periodic travel to the USA and Europe. Your work will ensure adherence to ISO 13485, MDSAP, and EU MDR requirements, supporting clients in delivering safe, effective products to market.
Key Responsibilities
- Perform on-site and remote audits to evaluate compliance with quality management systems and regulatory standards.
- Prepare detailed assessment reports and clearly communicate findings, including recommendations for corrective actions.
- Advise on certification decisions, including issuance, renewal, or withdrawal, in alignment with internal policies and timelines.
- Lead audit teams, ensuring consistent service quality and strong internal and client relationships.
- Build trusted advisory relationships with clients to support long-term compliance and business growth.
- Support internal teams with accurate data and client insights to maintain up-to-date records and service delivery.
- Coach junior auditors and contribute to team development, especially in technical areas involving microbiology and sterile processes.
- Stay current with evolving standards, regulations, and industry practices to maintain technical credibility.
- Promote ethical practices and organizational values while representing the company as a trusted advisor.
Qualifications and Experience
Applicants must hold a bachelor’s degree or higher in a relevant life sciences or engineering discipline, with at least five years of experience in quality or technical management within the medical device sector. Direct experience as a microbiologist in the production of sterile medical devices is essential. You should have hands-on knowledge of devices involving biological coatings, absorbable materials, or active implantable technologies.
Required expertise includes ISO 13485, EU MDR, and MDSAP frameworks. Familiarity with product certification principles, quality management systems, and business process integration is expected. Strong analytical abilities, attention to detail, and effective communication skills are crucial. The role demands self-direction, adaptability, and proven ability to manage time efficiently under pressure.
Work Environment and Travel
This is a locally based position in Taiwan with frequent domestic travel and overnight stays. Occasional international assignments will take you to the USA and Europe. You must be willing and able to maintain a demanding travel schedule.
Benefits and Development
- Access to comprehensive training programs, including lead auditor certification for ISO13485, MDSAP, and MDR.
- Opportunities to collaborate with global experts in standards, regulatory affairs, and healthcare innovation.
- Work within an inclusive, values-driven culture that emphasizes integrity, client focus, and continuous improvement.
- Be part of an organization committed to sustainability, ethical conduct, and advancing global safety and quality.
Company Values
The organization promotes agility, collaboration, and diversity, fostering a work environment where excellence is embedded in everyday practices. As an Equal Opportunity Employer, it actively supports inclusion and equitable opportunities for all professionals.
