Location
Boulder, CO | United States
Job description
Description:
- Implement and maintain QMS compliance for FDA, QSR and ISO 13485
- Prepare/submit FDA submissions including 510k
- Internal and external audit training and execution
Additional Skills & Qualifications: - 10+ years of QA/RA experience in medical devices
- Bachelors degree in sciences or related discipline
- Lead auditor training preferred
- Regulatory experience for ISO 13485, FDA CFR 820, IVDR, MDR
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email
[email protected] for other accommodation options.
Job tags
Salary