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Responsibilities:

• Manage engineering changes working with cross-functional team to ensure timely execution.
• Plan, prioritize, set goals and manage multiple projects in a technical and business environment
• Actively participate in continuous improvement efforts
• Perform root cause analysis of quality issues
• Recommend and implement cost effective permanent corrective actions
• Assist production with problem solving and developing standardized work for production operators, including boundary samples
• Strong communication skills to support meetings at all levels of the company, including senior leadership
• Exhibit a willingness to do things differently and consistently translate ideas into actions that deliver results
• Support the qualification and validation of new/changed processes and products, including performance.
• Assist in developing and improving quality system procedures as required.
• Perform testing, data generation and data analysis as necessary, through the knowledge and use of statistical problem solving techniques.
• Track, investigate and report on major quality issues and indicators necessary for the successful operation of the St. Louis quality system.
• Provide training and educational assistance.
• Supervise inspectors including methods, workload, performance, etc.
• Use supervisory skills to handle employee communications and employee relations within respective area or facility, as appropriate.
• Responsible for general plant rules and policies governing workplace performance and Environmental, Safety & Health policies and procedure compliance within respective functional area and facility, as appropriate.
• Responsible for Non-Conforming product Disposition, containment and investigation to eliminate reoccurrence

• Bachelor's degree in technical field
• Quality engineering certification preferred (CQE, SSGB, SSBB)
• Minimum 3 years quality experience; validation experience preferred
• Knowledge of quality, regulatory affairs, FDA regulations
• Experience with failure analysis and root cause
• Strong interpersonal skills with ability to work in a team environment