Quality Engineer

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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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.