Product Surv Quality Assoc II Job Details

Requirements

* Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211).
* Understanding of the products intended use and manufacturing process of assigned products.
* Readily accepting of assignments to new/different products.
* Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
* Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management
* Excellent written/verbal communication and organizational skills
* Ability to make independent decisions with minimum oversight
* Strong problem solving and analytical skills
* Demonstrated critical thinking ability
* Solid written/verbal communication and organizational skills
* Demonstrated project management experience
* Working knowledge of lean principles (i.e. Six Sigma)

Education and Experience:

* Bachelors degree (life sciences preferred) or clinical certification (MT, RN) or equivalent experience (defined as a minimum of 5 years of medical products industry experience)
* 2+ years of relevant work experience in cGMP related industry or in a clinical setting
* Project Management experience and/or certification preferred
* Application of lean principles preferred

Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.