Our client is a rapidly growing medical device company looking to fill a critical role for a quality and regulatory manager.  This is a Utah facility that has been expanding and expects to double their staff in the next 3 years which will create additional opportunities for career development and advancement.  This is a great group of people that works closely together where you will be close to the decision makers and will be looked to for your expertise in how to improve the companies quality system, particularly in the area of process validation and risk management.  This company is in a very favorable financial position.  This is a real opportunity for you to put your mark on the companies quality system.  If this sounds like the right opportunity for you, please reply to this posting for immediate consideration. 

Minimum requirements: 

1)      Bachelors of Science

2)      5+ years of medical device or pharma experience

3)      5+ years of experience with EO sterilization

4)      Demonstrated knowledge of FDA regulations including 21 CFR 820 and ISO 13485 standards.

5)      Direct experience with FDA and ISO notified bodies

6)      Knowledge of process design and implementation, auditing, and document management systems

Preference:

1)      Demonstrated knowledge of statistical analysis

2)      Preference for person bi-lingual in English and Spanish

Our client offers:

1)      A fast paced, challenging work environment with opportunities for career growth

2)      Outstanding benefits including medical, dental and PTO for full time employees

3)      Bonus plan

We regret that we cannot accept applications from candidates who do not possess all of the specified minimum requirements.

For immediate consideration, please email your resume in Word format to mgfresume@mrislc.com