What are the responsibilities and job description for the Auditor, Medical Devices - Full-Time position at Intertek Testing Services NA Inc?
Medical Device Auditors - Full-time - USA remote with extensive travel. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for a Medical Device Auditor that wants to build something great with an incredible group of people.
By joining Intertek, your contributions will be valued as we continue to help the world Build Back Ever Better. Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful.
Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace. What are we looking for? The Auditor, Medical Devices will support the Business Assurance business by leading and / or participating as an assessor during all phases of a client's management system, in accordance with the company's accredited certification program.
The Auditor is the primary interface with the client before and during the process of all auditing activities.
Additionally, the Auditor will help train low-graded Auditors through witness audits, technical support, and education of both client and sales force as needed. This will be a travel-based position, with extensive travel to client sites required.
Candidate must be comfortable traveling 3 to 5 nights per week.
This is a remote position; however, applicants must reside in and be able to legally work in the United States. Salary & Benefits Information Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons. In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more. What you'll do :
- Audit client management systems for compliance with established standards, client, and / or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and / or Brazil, and / or GMP regulatory requirements related to the medical device, pharmaceutical and / or cosmetic industry.
- Assist clients with questions relevant to the audit and / or certification process.
- Act as Lead Auditor or team member.
- Travel will include overnight 3 to 5 days per week, to various worksites and client locations.
- Coordinate audit activity with team members.
- Liaison with client regarding audit activity.
- Review client's quality management system documentation
- Verify and document evidence of compliance and non-compliance.
- Prepare audit report.
- Review audit results with coordinator and other assessment team members.
Make presentations to clients and / or certification board concerning audit results, when required.
The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties. Minimum Requirements & Qualifications :
Primarily domestic travel, some international travel may be needed.
sterilization, machinery, electric and electronic devices or components, software development).
Body agility is emphasized.
Assured. Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts.
With passion, pace, and precision we work to exceed our customers' expectations, while engaging with our employees to be 10X in their performance and professional growth. Intertek is a drug-free workplace.
As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed. We Value Diversity Intertek's network of phenomenal people are our greatest assets, and the diversity they bring fuels our success.
Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity.
We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics. For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department. #LI-Remote #LI-JC1
Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains.
Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.
