Contract Medical Device Lead Auditor

Your role

Medical Device Lead Auditor

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. Position is home based with extensive travel.

Job Responsibility:

• Knowledge of principles and methods for management systems audits.

• Experience with internal, 2nd or 3rd party ISO-9001, ISO 13485, and/ or GMP auditing.

• Preference given to RAB-QSA or Exemplar Global Lead Auditor or Auditor qualification.

• 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.

Your profile

• 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.

• Experience in implementation of ISO 13485, MDD and/ or CMDCAS desired.

EEO is the Law
Right to Work Poster (English)

DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled

EQUAL EMPLOYMENT OPPORTUNITY (EEO)

Qualified applicants are considered for employment without regard to race, religion, sex, national origin, age, marital status, sexual orientation, veteran status, disability, or other protected characteristic.

The employer is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their race or ethnicity. Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. When reported, data will not identify any specific individual.

Right to Work Poster (English)

EEO is the Law

Why Work With Us

At DQS, you will work on issues that matter – for companies and for society. Our audits and certifications not only create trust and competitive advantages, but also contribute to greater sustainability, safety, and responsibility in global supply chains. Those who work at DQS actively shape how companies worldwide live quality and fulfill their social obligations – soundly, independently, and effectively.

About Us

DQS empowers organizations worldwide to build trust, drive innovation, and achieve sustainable growth by certifying the future of business. Founded in 1985, DQS has grown into a global leader in the assessment and certification of management systems, with a team of 2,500 highly qualified auditors delivering over 125,000 audit days per year in more than 60 countries. 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.

Thinking beyond compliance, DQS is a trusted partner for digitalization, automation, and sustainability leadership. 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 People

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 & Inclusion

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.

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Want to gain more insight into our work, our values, and our people? Follow DQS on LinkedIn and discover what drives us—from customer projects to sustainability to career opportunities. We look forward to connecting with you!