IVDR Auditor & Assessor
- Shanghai
- Permanent
- Full-time
- Take ownership of achieving personal KPI targets in alignment with team and organizational goals.
- Perform ISO 13485 and IVDR audits and assessments efficiently and competently, in accordance with CE regulations, international standards, applicable regulatory systems, and the company's certification programs.
- Ensure all work is carried out with the highest level of independence, integrity, and professionalism.
- Support continuous improvement by identifying and implementing enhancements to audit processes, information handling, and cross-functional collaboration within the organization.
- Plan, organize, and deliver various client projects, including assessments, gap analyses, trainings, and customer workshops.
- Maintain active auditor/assessor registration and qualifications to perform designated duties.
- Undertake additional tasks as assigned by the Line Manager.
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Sick leaves policy/ Annual leaves policy)
- Medical benefits - Annual Health Check-up
- Pension and Insurance Policies - (Pension Insurance, Medical Insurance, Unemployment Insurance, Work related injury insurance, Supplementary Pension)
- Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
- Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Housing Fund, Lunch Policy)
- Profit Share/ Chinese New Year Bonus
- Bachelor's degree or higher in a relevant field such as Biology, Microbiology, Chemistry, Biochemistry, Medical Technology, Clinical Medicine, Biomedical Science, Software Technology, Electrical/Electronic/Mechanical Engineering, or Bioengineering.
- At least 4 years of experience in the design, manufacturing, testing, or clinical use of In-Vitro Diagnostic (IVD) medical devices, gained in industry, academia, or hospital environments.
- Prior experience in auditing and assessment within a Notified Body, particularly in the IVD field, is preferred.
- Quality Management System (QMS) auditing experience is desirable; preference given to CCAA-registered QMS auditors.
- Strong customer focus with excellent communication and collaboration skills.
- Fluent in both written and spoken English.
- Capable of managing a high workload and open to frequent travel.