Senior Lead Auditor - Medical Devices

DNV careers•Houston, TX

5d•Hybrid

About The Position

DNV Business Assurance USA, Inc. seeks a Senior Lead Auditor - Medical Devices to work for our office in Houston, TX. Job Duties: Efficiently and competently implement ISO13485 & MDR auditing and assessment work for clients based on the CE Directives, International standards, other applicable Regulatory Systems and DNV's accredited certification program. Schedule and plan audit activity with customers. Interact directly with customers at all levels of management in developing timely, complete and accurate reports of their current level of compliance or implementation of their management system. Document and report audit activities and results. Provide timely and accurate reviews of customer corrective action and closure. Maintain appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed. Responsible for achieving KPI-targets. Ensure work is executed with absolute independence, and integrity at all times. Contribute to the ongoing improvement of operational efficiency and effectiveness by means of the identification and pursuit with regards to audit processes and handling of information within the team and unit, facilitating the rendering of service also to other functions within the organization as required. Organize and deliver projects, i.e., assessment, gap analysis, training and customer workshops, etc. Maintain assessor/auditor registration with DNV and other relevant authorities to work as a Senior Auditor at DNV. This position requires 85% domestic, 5% international travel to client sites. Role is hybrid allowing periodic work from within a reasonable commuting distance of the Houston, TX office.

Responsibilities

Implement ISO13485 & MDR auditing and assessment work
Schedule and plan audit activity with customers
Interact directly with customers at all levels of management
Document and report audit activities and results
Provide timely and accurate reviews of customer corrective action and closure
Maintain appropriate audit credentials and pursues advancement of those credentials
Responsible for achieving KPI-targets
Ensure work is executed with absolute independence, and integrity at all times
Contribute to the ongoing improvement of operational efficiency and effectiveness
Organize and deliver projects, i.e., assessment, gap analysis, training and customer workshops, etc.
Maintain assessor/auditor registration with DNV and other relevant authorities