Contract Medical Device Lead Auditor

DQS • Schaumburg, IL

1d • Remote

About The Position

DQS Inc. has an immediate contract opportunity for a Medical Device Lead Auditor. Working closely with your schedulers, you will visit client locations and perform the audits as specified. This position is home-based with extensive travel.

Requirements

• Bachelor’s degree in a physical or life science or electrical, mechanical or biotechnology engineering required
• Minimum of four years experience in quality systems management.
• Minimum of four years experience in medical device development, manufacture and/or testing, with demonstrated knowledge of US, Canada and EU medical device regulatory requirements, experience with device submittals and knowledge of risk management principles such as ISO 14971.
• Passed or ability to pass an accredited 40-hour ISO 9001 or ISO 13485 lead auditor course.

Nice To Haves

• Preference given to RAB-QSA or Exemplar Global Lead Auditor or Auditor qualification.
• Experience in implementation of ISO 13485, MDD and/ or CMDCAS desired.

Responsibilities

• Knowledge of principles and methods for management systems audits.
• Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing.
• Ability to develop an audit scope and audit plan and manage audit team activities.
• Ability to present the audit team conclusions to the customer and review customer resolution of any nonconformities.
• Must be able to assess customer needs and meet UL DQS service and customer satisfaction standards.
• Work independently and project a professional image appropriate to the work environment.
• Extensive travel.

Benefits

• DQS empowers organizations worldwide to build trust, drive innovation, and achieve sustainable growth by certifying the future of business.
• Through internationally recognized certifications across 200+ standards, DQS helps businesses manage risks, ensure compliance, and unlock new opportunities in an evolving regulatory and business landscape.
• The company’s expertise covers a wide range of areas, spanning from cybersecurity and AI governance to ESG compliance, supply chain management, medical device safety, and future mobility, delivering real value to industries in their pursuit of resilient, sustainable, and intelligent systems.
• By leveraging advanced auditing methodologies, predictive analytics, and real-time insights, DQS supports organizations to future-proof their operations while demonstrating their commitment to excellence and responsible business practices.
• Our employees are the heart of DQS. With their professional excellence, team spirit, and passion, they make a difference—for our customers, for our further development, and for a sustainable future.
• At DQS, expertise meets appreciation and a working environment that promotes trust and responsibility.
• Diversity is part of our identity at DQS. In our global team, we promote a working environment in which different perspectives, experiences, and life paths are welcome—regardless of origin, gender, age, or individual abilities.
• Through flexible working models, fair development opportunities, and inclusive structures, we create space for everyone to reach their full potential.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior