Auditor, Medical Devices, Qualified 3rd Party Experienced - Full-Time

Intertek•United States,

15d•Remote

About The Position

Intertek's Business Assurance team is seeking an experienced Notified Body and MDSAP Auditing Organization 3rd Party Qualified Medical Device Auditor to join their team. This role 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 will be the primary interface with the client before and during all auditing activities. Additionally, the Auditor will assist in training lower-graded Auditors through witness audits, technical support, and education of both clients and the sales force. This is a travel-based position requiring extensive travel to client sites, with candidates expected to travel 3 to 5 nights per week. It is a remote position, but applicants must reside in and be legally able to 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 in a 3rd Party Auditing with Lead Auditor qualification in MDSAP and ISO 13485:2016 with an up to date audit log.
A minimum of 4+ years of full-time work experience in a medical device or related medical device industry (design, development, testing, quality assurance/quality control).
A minimum of 2+ years in a quality management systems environment (auditing, CAPA, complaints, management review).
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 (typically includes USA+Canada+Mexico).
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.

Nice To Haves

Lead Auditor Training with (ISO19011 OR ISO13485) Certification
MDR Notified Body auditing experience
Related 3rd party auditing industry management systems experience with 3rd party audit log with 6 audits for a total at least 15 audit-days per 12-month period with at least 2 of these audits being initial or recertification audits and Lead Auditor role in at least 2 of these 6 audits within the last 12 months
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 regulatory requirements.
Device Industry experience with Orthopedic implants, Active devices, Software as a medical device, Monitoring devices, IVF and ART devices, and sterility requirements (ETO, GAMMA).
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.).

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.
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.