Auditor, Medical Devices - Full-Time

Intertek

3d•Remote

About The Position

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.

Requirements

4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
A minimum of 4+ years of full-time work experience (design, development, testing, quality assurance/quality control) in a medical device or related medical device industry
A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review)
Completed Lead Auditor training for any standard (preferably ISO 13485 and/or relevant regulatory requirements), but will train if needed.
Strong communication and interpersonal skills.
Sound judgment, organizational, and analytical skills.
Excellent computer and writing skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to exercise effective time management skills in completion of assignments.
Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed.
Possess a valid unrestricted driver’s license and the ability to operate a motor vehicle in the performance of the official duties of the position.
This is a remote position; however, applicants must reside in and be able to legally work in the United States.
Active Medical devices (electronics/electrical)
Software (writing/validation of software for a device or software as a medical device)
Monitoring Devices
Dental Devices and Accessories
Wound Care devices
Non-active cardiovascular implants
Non-active orthopedic implants
Non-active functional implants
Medical gas supply systems and parts thereof
Imaging/Therapeutic devices using ionized radiation
Experience with requirements for Sterilization – GAMMA/Radiation
Experience with requirements for Sterilization - EO
Experience with requirements for Sterilization - Moist and Dry heat

Nice To Haves

Lead Auditor Training with (ISO19011 OR ISO13485) Certification
Related 3rd party auditing industry management systems experience.
Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada.
Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, pharmaceutical, and/or cosmetic regulatory requirements.
Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization, machinery, electric and electronic devices or components, software development).
Training/experience in quality tools (Kaizen, lean manufacturing, etc.).
Working experience in a wide range of medical devices.

Responsibilities

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:
This will be a remote/home-based position, with extensive travel to client sites required
Travel will include overnight/multiple days, 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.