Senior Lead Auditor - Medical Devices

DNV•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. This role involves implementing ISO13485 & MDR auditing and assessment work for clients based on CE Directives, International standards, and other applicable Regulatory Systems. The position requires scheduling and planning audit activity, interacting with customers at all management levels, and developing accurate reports on compliance. Responsibilities include documenting and reporting audit activities, reviewing customer corrective actions, and maintaining audit credentials. The role also involves achieving KPI targets, ensuring work is executed with independence and integrity, and contributing to operational improvements. Organizing and delivering projects such as assessment, gap analysis, training, and customer workshops is also part of the duties. The position requires 85% domestic and 5% international travel. This role is hybrid, allowing periodic work from within a reasonable commuting distance of the Houston, TX office.

Requirements

Maintain appropriate audit credentials
Pursue advancement of credentials
Maintain assessor/auditor registration with DNV and other relevant authorities

Responsibilities

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.