IVDR Auditor & Assessor
IVDR Auditor & Assessor
Posted on :
23-08-2025
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1 Vacancy
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Job Description
Description
Responsibilities
Qualifications
IVDR Auditor & Assessor
Responsibilities :
- 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 companys 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.
Responsibilities
- 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
*Benefits may vary based on position tenure/contract/grade level*
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender religion race national or ethnic origin cultural background social group disability sexual orientation gender identity marital status age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
Qualifications
- Bachelors 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.
Employment Type
Full Time
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