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ISO 13485 & MDR Compliance Auditor

2 months ago

Shanghai, Shanghai, China DNV Full time

Position Overview: This role focuses on the certification of medical devices, ensuring compliance with relevant standards and regulations.

Main Responsibilities:

  • Achieve personal KPI targets to drive performance.
  • Conduct ISO 13485 and MDR auditing and assessment for clients, adhering to CE Directives and international standards.
  • Maintain independence and integrity in all audit processes.
  • Enhance operational efficiency by identifying improvements in audit processes and information management.
  • Organize and facilitate projects, assessments, gap analyses, training sessions, and customer workshops.
  • Keep auditor registration with DNV and relevant authorities to serve as a Lead Auditor.
  • Perform additional tasks as assigned by management.

Benefits:

  • Flexible work arrangements to promote work-life balance.
  • Generous paid leave policies, including sick and annual leave.
  • Comprehensive medical benefits, including annual health check-ups.
  • Pension and insurance policies covering various aspects such as medical, unemployment, and work-related injuries.
  • Support for training and development through sponsorship and on-the-job training.
  • Additional perks such as long service awards and mobile phone reimbursement.
  • Profit-sharing opportunities and bonuses during festive seasons.

Qualifications:

  • Bachelor's degree or higher in a relevant field related to medical science or medical devices.
  • 2-4 years of experience in the medical device industry, with at least 1-2 years in clinical settings.
  • Preferably possess auditing experience and registration as a QMS auditor.
  • Strong customer focus and excellent communication skills.
  • Ability to work collaboratively within a team.
  • Fluency in written and spoken English is essential.
  • Willingness to manage a high workload and travel frequently.

Diversity Commitment: DNV is an Equal Opportunity Employer, valuing diversity and inclusion in the workplace.