Auditor, Medical Devices Full-Time

Medical Device Auditors - Full-time - USA remote with extensive travel.

Interested in futurecareeropportunities in the Quality Assuranceaudit and support services industryWerelooking foraMedical Device Auditorthat wants to build something great withan incredible group of people. By joiningIntertek your contributions will be valued as we continue to helpthe worldBuildBackEverBetter.

Interteks 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 clients 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 clients management system in accordance with the companys 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-basedposition 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.

We are looking to hire within the next 4-6 months

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 youll 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:
  • 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 clients 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 (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 drivers 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.

Skills most needed:

• 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

Preferred Requirements & Qualifications:

• 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 industrys 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.

PHYSICAL REQUIREMENTS:

This role requires the ability to:

• Ascend or descend ladders stairs ramps and the like using feet and legs and/or hands and arms. Body agility is emphasized.
• Stand for sustained periods of time.
• Walk moving on foot to accomplish tasks and to move from one work location to another.
• Communicate well thru spoken word conveying detailed accurate information & instructions to others.
• Hear well perceiving sounds with or without correction including the ability to receive information thru oral communications.
• Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift carry push pull or otherwise move objects.
• Have close visual acuity to perform an activity such as preparing & analyzing data viewing a computer monitor reading report writing visual inspection and use of measurement devises.

Intertek: Total Quality. 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

Interteks network of phenomenal peopleare 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 call 1- (option #5) to speak with a member of the HR Department.

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*Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume.