Auditor, Medical Devices - US - Intertek Testing Services NA Inc

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.

Our Value Proposition - We offer:

• A flexible work schedule & the ability to work from home
• Competitive wage and benefits package including paid time off, medical, dental, vision, life, and disability
• 401(k) with company match
• Opportunity for growth (over 100 locations with opportunity for growth/advancement/relocation)
• Employee referral bonuses

What will you be doing?

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. Primarily based on the West Coast, with potential travel to other US regions based upon company needs.

Duties:

• 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.

REQUIRED:

• 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 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 (CAPA, internal auditing, supplier complaints, management reviews)
• 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.

PREFERRED:

• 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

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.

Why work at Intertek?

Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about Our History and What We Do .

What we have to offer:
When Working with Intertek , you can expect salary competitively placed within the local market.

Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test.

Intertek believes that Our People are our strongest tool for success. We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.

For individuals with disabilities who would like to request an accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

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#LI-JC1Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.