Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply on company site

You’re being taken to an external site to apply.

Create an account to get recommended jobs that match your resume and apply to multiple jobs in seconds!
On the next page, you'll build a resume in 3 steps thanks to our AI technology
8-15 characters
Contains Number
Contains Lowercase
Contains Uppercase
Contains Special Character
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
17cf55953a615ac6eaa486e1f70b58c5

ISO 13485 Lead Auditor

DNV GL Katy, TX Full-Time
Apply on company site
Local Unit & Position Description

DNV GL - Business Assurance North America is seeking an ISO 13485 Lead Auditor. The ISO 13485 Lead Auditor partners with clients in the Medical Device industry to improve the quality and safety of their business performance through the application of internationally recognized standards.DNV GL Business Assurance North America is a leading provider of accredited management systems and product compliance certification.

We offer a broad portfolio of services across a variety of disciplines and industries. Our auditors are generally based remotely allowing them to work independently as they travel to client sites while receiving a full complement of administrative support from our central office in Katy, TX. 

Tasks May Include

  • On-site and off-site technical assessments of Medical Devices against Medical Device Directive
  • Perform 3rd party on-site ISO 13485 (Medical Device) audits for North America customers
  • 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
  • Maintains appropriate audit credentials and pursues advancement of those credentials and other related credentials as needed


Position Qualifications

Requirements

  • Must have a Bachelors Degree or higher in biology or microbiology; chemistry or biochemistry, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics or other related fields
  • Must have a minimum of 4 years experience in the medical devices industry
  • Must be currently approved as a competent Lead Auditor for ISO 13485 by a Certification Body – Third Party certification Lead Auditor? (NO Exceptions)  
  • Must have a minimum of 1 year of expedience as ISO 13485 Third Party certification Lead Auditor? 
  • Must Have a working knowledge of ISO 13485 Codes: MD0100, MD0105, MD0200, MD0203
  • Must have a working knowledge of ISO 14971, medical device risk management 
  • Must have successfully completed training and competence evaluation within Medical Device Directive and ISO 13485
  • Must be willing and able to travel to client sites up to 100% of the time
  • Must have demonstrated excellent customer service skills
  • Must possess a valid driver’s license and be able to rent and drive a car and travel on public conveyances when required
  • Must have the ability to work independently and in teams
  • Must be analytical, empathetic and able to communicate effectively, respond calmly and make decisions
  • Must be able to walk and stand for up to 4 hours at a time and maneuver throughout multiple levels of client sites either by stairs or elevator?
  • Must be able to lift and carry up to 10 pounds in addition to transporting one’s own luggage for multiple-day travel and push, pull reach, bend, twist, stoop and kneel with that which is lifted, carried or transported
  • We conduct pre-employment background check and drug screen

Opportunities Beyond Business
Our mission is to safeguard life, property and the environment. By joining us, you will work towards our meaningful vision: to make a global impact for a safe and sustainable future. DNV GL offers a congenial working environment, competitive salaries, and an exceptional benefits package.

DNV GL is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to race, color, religion, age, sex, national origin, disability or protected veteran status.  For more information about your rights under the law, see:[ Link removed ] - Click here to apply to ISO 13485 Lead Auditor  

Local employment conditions apply. 

Please visit our website at [ Link removed ] - Click here to apply to ISO 13485 Lead Auditor



Company & Business Area Description

Driven by our purpose of safeguarding life, property and the environment, DNV GL enables organisations to advance the safety and sustainability of their business. We provide classification and technical assurance along with software and independent expert advisory services to the maritime, oil & gas and energy industries. We also provide certification services to customers across a wide range of industries.

Combining leading technical and operational expertise, risk methodology and in-depth industry knowledge, DNV GL empowers our customers’ decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.

Originated in 1864, DNV GL operates globally in more than 100 countries with our 15,000 professionals dedicated to helping our customers make the world safer, smarter and greener.

As a world-leading certification body, we work with companies to assure the performance of their organisations, products, people, facilities and supply chains through certification, verification, assessment and training.  As part of the larger DNV GL Group, our 2,000 Business Assurance employees worldwide help our customers build sustainable business performance and create stakeholder trust.  We promise to be focused on your future.

With more than 70,000 certificates issued worldwide, our name evokes a strong commitment to safety, quality, and concern for the environment. For years, we have been the preferred certification partner for many Fortune 500 companies, as well as for medium and smaller businesses.  

With our extensive local presence, consolidated global experience across industries and acknowledged technical competence, we are an ideal partner for companies in all sectors. We partner with our customers to help them create value while meeting the world’s economic, social and environmental needs.

Through our certification, verification, assessment and training services, we assure the performance of our customers’ organisations, products, people, facilities, and supply chains.  Working with companies in most industries, and some of the world’s leading brands, in practice, we are virtually everywhere.

 

Recommended skills

Chemistry
Biology
Microbiology
Scheduling
Biochemistry
Biophysics

Location

Career Path

See the next step in your career
ISO 13485 Lead Auditor
Estimated Salary: $75K
Apply to this job.
Think you're the perfect candidate?
Apply on company site

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: 2020-13685

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.