Responsibilities and experience may include the following: Quality review/guidance durign design controls for combination products (medical devices). Operational Excellence and/or ASQC certifications. Change management. Risk based management. Project management tools. Process flow diagram and process map. Participates in the development of new systems/operations required to manufacture clinical materials. Supports the evaluation and lifecycle of all aspects of change management. Identifies root causes and recommends/implements corrective actions/preventive actions.

Position:
Minimum 3 years in biotechnology related industry or medical device industry. Preference for previous experience with combination products. Prefered experience 5+ years. Desired certifications: ASQ CQE/CQA.   Education:
Bachelors in Engineering (preferably checmical or mechanical) Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation