Joining TÜV Rheinland means working for one of the world’s leading testing, inspection, and certification service providers with more than 25,000 employees globally. Our employees are our most important asset. That is why we invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match. At the same time we live an international, team-oriented culture characterized by respect, collegiality and openness. This enables our employees to develop their potential, apply new knowledge and methods directly - and plan a long-term career with real opportunities for advancement.

SUMMARY

The Auditor Lead position is responsible for evaluating clients' medical device management systems against international standards and regulations, leveraging their expertise in in vitro diagnostic devices and related technologies. They work independently and as part of a team and may also serve as Product Specialists. The role involves a combination of auditing and technical documentation reviews, depending on their background.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• ■Plan, perform and document certification audits, surveillance audits, re-certification and unannounced audits a following relevant published standard(s), regulatory requirements, and company procedures, such as ISO 13485, MDSAP, EU MDR, EU IVDR, and UK MDR
• ■Lead audit team and be responsible for successful accomplishment of assigned project
• ■Write, submit, and correct audit reports, client responses to audit nonconformities, and other technical documentation reports
• ■Inform management through verbal and written communication of compliance issues, relevant standards, and regulatory requirements
• ■Evaluate product non-conformance related to product processes and specifications
• ■Evaluate and support vigilance cases as assigned
• ■Establish and maintain strong professional relationships with customers
• ■Maintain and expand technical expertise in specific product fields
• ■Support colleagues with training, workshops and sharing or knowledge, as required
• ■Perform other duties as assigned
• ■QUALIFICATIONS & REQUIREMENTS:

Knowledge, Skill, & Abilities

• ■Broad knowledge of domestic and international regulatory compliance laws and regulations, including specific product directives
• ■Ability to read and interpret documentation for compliance with procedures, standards, and regulations.
• ■Ability to communicate with client’s highly specialized scientists, engineering, quality, technical and regulatory employees.
• ■Must be highly organized and able to work independently.
• ■Technical expertise in product field with relevant practical experience in the field of healthcare products, such as in vitro diagnostic devices or, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
• ■Ability to travel domestically and internationally.
• ■Valid passport and driver’s license required.

Education

• ■Bachelor’s Degree in Life Science (Biology, Chemistry, Medicine, and Pharmacy) or equivalent education and/or experience
• ■Masters or PhD desirable

Experience

• ■2+ years of experience working with individual in vitro diagnostic products.
• ■4+ years full-time work with relevant practical experience in the field of healthcare products, such as in vitro diagnostics industry, science, laboratories, notified bodies, examination centers or facilities that assess or manufacture medical devices.
• ■Computer literacy required including Microsoft Office applications.

Certifications

• ■Auditor certification desirable (ASQ, IRCA, Exemplar Global)
• ■SUPERVISORY REQUIREMENTS:
• ■Direct: N/A
• ■Indirect: N/A

• ■PHYSICAL DEMANDS & WORK ENVIRONMENT
• ■Will work in an office environment from home, work office location or client location
• ■Physical activities for this position will constantly include: Communicating with other to exchange information; assessing the accuracy, neatness and thoroughness of the work assigned; and will occasionally include: ascending or descending ladders, stairs, scaffolding, ramps poles, and the like; moving self in different positions to accomplish tasks in various environments including tight and confined spaces; remaining in a stationary position, often standing or sitting for prolonged periods; repeating motions that may include the wrists, hand and/or fingers; Operating motor vehicles or heavy equipment.
• ■Environmental Conditions for this position will Occasionally include Low temperatures; High temperatures; Outdoor elements such as precipitation and wind; Noisy environments; Hazardous conditions; Poor ventilation; Small and / or enclosed spaces.
• ■Physical demands for this position will constantly include sedentary work that primarily involves sitting/standing; and will occasionally include physical efforts may require lifting 10 up to 10 pounds.

Equipment Used

• ■Laptop or Desktop Computer
• ■Phone / Cell Phone or Headset

Travel Required

• ■Ability to travel up to up to 75% may be required for this position.

TUV Rheinland North America EEO Statement

As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law. TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.

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