Auditor,Medical Devices Job Northern Kentucky USA,Quality Assurance

Medical Device Auditors
- Full-time
- Travel based Auditor.

Interested in futurecareeropportunities in the Quality Assurance audit and support services industry?

We’relooking for
aMedical Device Auditor
that wants to build something great withan incredible group of people. By joining

Intertek, your contributions will be valued as we continue to helpthe 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.

medical
dentist
vision
life
disability
401(k) with company match
generous vacation / sick time (PTO)
tuition reimbursement
and more

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 5days 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.
Assist with corrective action requirements resulting from assessments.
Participate in audit meetings.
Review audit reports and provide technical assistance to the medical team.
Support management in areas of continuous improvement.
Provide management with updates on status of work, initiatives, and projects, as required.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Minimum

Requirements & Qualifications:

4 year college/university degree in a science or technical field…