Title: Quality Engineer
Location: Phoenix, AZ area
Start Date: ASAP!
Duration: Direct Hire
Hours: Mon-Fri; 8am-5pm

Degree:
- Minimum of a BS degree in scientific or engineering discipline (chemistry, biology, physics, biomedical engineering, etc.) or equivalent
- Master's Degree is preferred

Experience/"Must Haves":
- Minimum of 3-5 yrs. quality engineering experience in a regulated environment (preferably Med Device or Pharma industry) is a must!
- Minimum of 3 yrs. exp. participating in equipment qualification, process validation, protocol generation and report writing is a must!
- CQE, CQA, Six Sigma Certifications, or the ability to obtain them within 12 months, preferred
- Exp. in applying statistical methods and statistically evaluating test results using tools such as Minitab 
- Exp. with device packaging and sterilization validation/monitoring

Duties/Responsibilities:
- Support the overall Validation Program and approach at the site level through continuous improvement and ensuring compliance with GMPs, GTPs, and GDPs
- Effectively communicate and reinforce commitment to quality improvement efforts by performing process stability and capability studies as needed/assigned on processes
- Actively support Product Development and Manufacturing Engineering projects or activities, which may include, line extensions, SKU development, process improvements, qualification, or validation, etc.
- Review and analyze associated results and recommend changes to processes based upon findings, leading to a verification of effectiveness
- Support the Product Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Participate in FMEA (or other risk assessment tools) generation activities as requested
- Perform, or participate in, product impact / risk assessments for non-conformances, CAPAs, etc.

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