[Hiring] Auditor, Medical Devices, Qualified 3rd Party Experienced @Intertek

Role Description

Experienced 3rd Party Qualified Medical Device Auditors - Full-time - Travel based Auditor. Interested in future career opportunities in the Quality Assurance audit and support services industry? We're looking for an experienced Notified Body and MDSAP Auditing Organization 3rd Party Qualified 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.

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.

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 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.

Requirements

• 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.).

Benefits

• Competitive compensation packages.
• Medical, dental, vision, life, and disability insurance.
• 401(k) with company match.
• Generous vacation/sick time (PTO).
• Tuition reimbursement.
• And more.

Physical Requirements

• Able to ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms.
• Stand for sustained periods of time.
• Walk, moving on foot to accomplish tasks and to move from one work location to another.
• Communicate well, through spoken word, conveying detailed accurate information & instructions to others.
• Hear well, perceiving sounds with or without correction, including the ability to receive information through 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 activities such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices.