Senior Lead Auditor - Medical Devices

DNV•Houston, TX

4d•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 efficiently and competently implementing ISO13485 & MDR auditing and assessment work for clients based on CE Directives, International standards, other applicable Regulatory Systems and DNV's accredited certification program. The position requires scheduling and planning audit activity with customers, interacting directly with customers at all levels of management, and developing timely, complete, and accurate reports of their current level of compliance or implementation of their management system. Responsibilities include documenting and reporting audit activities and results, providing timely and accurate reviews of customer corrective action and closure, and maintaining appropriate audit credentials. The role also involves achieving KPI targets, ensuring work is executed with absolute independence and integrity, and contributing to the ongoing improvement of operational efficiency and effectiveness. Additionally, the Senior Lead Auditor will organize and deliver projects such as assessments, gap analyses, training, and customer workshops, and maintain assessor/auditor registration with DNV and other relevant authorities. This position requires 85% domestic and 5% international travel to client sites. The role is hybrid, allowing periodic work from within a reasonable commuting distance of the Houston, TX office.

Requirements

Bachelor’s degree in Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical engineering or Bioengineering, Human Physiology, Medicine or Veterinary Medicine, Pharmacy, Physics or Biophysics, Food Science or related field of study and four (4) years of experience as a Medical Device Auditor, Lead Auditor or related role where required experience gained.
In lieu of a Bachelor’s degree in above stated fields and four (4) years of above stated experience, employer will accept a Master’s degree in Biology or Microbiology, Chemistry or Biochemistry, Computer and Software Technology, Electrical, Electronic, Mechanical engineering or Bioengineering, Human Physiology, Medicine or Veterinary Medicine, Pharmacy, Physics or Biophysics, Food Science or related field of study and two (2) years of experience as a Medical Device Auditor, Lead Auditor or related role where required experience gained.
Two (2) years of experience in medical device or healthcare industry, medical device audits or research in medical devices.
Entire process of auditing medical device quality management systems, including documentation review, risk management of applicable medical devices, implementation audit, and audit reporting with an accredited CB/NB.
Participated as a trainee in a minimum of four audits, totaling at least 20 days in an accredited QMS program, with at least 50% of that time against ISO 13485, in an accredited program.
Acting in a team leader role under the supervision of a qualified team leader for at least three ISO 13485 audits.
20 audit days in ISO 9001/ISO 13485 or combination of both as a 3rd party lead auditor.

Nice To Haves

ISO 13485:2016 36-40 Hour lead auditor certification
MDR Training
MDSAP Training
ISO 14971:2019 Training

Responsibilities

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.