ISO13485 lead auditor certification Required

Required Skills
* Proven expertise in MS Office Suite
* Excellent written and verbal communication skills in Local Language including negotiating and
relationship management skills
* Excellent written and verbal communication skills in English
* Excellent problem-solving and critical thinking skills
* Substantial knowledge and understanding of policies, procedures, and guidelines relevant to
quality systems
* Substantial knowledge of medical or pharmaceutical regulations as relating to documentation (e.g.
Good Documentation Practices, Post Market Surveillance, Labeling Rules)
* Substantial understanding of medical devices regulations (e.g., ISO13485, Local Regulatory
Requirements)
* Strict attention to detail

* Ability to interact professionally with all organizational levels, internally and externally
* Ability to manage competing priorities in a fast-paced environment
* Work is performed independently on more complex projects and/or lines of work and reviewed for
accuracy and soundness
* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health &
Safety rules) and take adequate control measures in preventing injuries to themselves and others as well
as to the protection of environment and prevention of pollution under their span of influence/control

experience

10