Engineer (Quality) II

JOB RESPONSIBILITIES/REQUIREMENTS:
Works both collectively with a team and individually to administer, evaluate, maintain, modify and improve quality methods, processes and programs that support products manufactured and distributed by Redmond Operations.This position will be responsible for working collaboratively with others to assess process risk, investigate root cause and implement effective long-term corrective action to prevent recurrence of identified quality issues.The position is also responsible for analyzing quality information to identify ineffective corrective action and new opportunities for improvement and advising teams with respect to sound approaches for investigation management, risk mitigation, statistical techniques, and overall quality system support.
Skills and Experience:
QUALIFICATIONS:
Bachelor's degree in a science/technical field or related discipline. Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Black Belt (CSSBB) status desired.Minimum of three years experience in a manufacturing /QA environment where typical activities include performing quality engineering tasks such as failure investigations, risk assessment, validation study design/execution, application of statistical concepts and/or related quality planning for commercially distributed products.Experience working under FDA regulations and ISO standards. Experience with the development, manufacture or support of in vitro diagnostics or biological products is highly desirable.Excellent written and verbal communication, interpersonal, presentation, project management, and organizational skills. Strong computer skills including knowledge of Microsoft Office applications Word and Excel required.Proficiency with Minitab for statistical analysis is also desired.