Job Summary Develops, applies and maintains quality requirements and standards for manufacturing products and testing. · Design and implement methods for process control, process improvement, testing and inspection · Lead problem-solving teams to achieve improvements · Investigate customer complaints, yield issues, and other process failures and initiate corrective and preventive action as appropriate · Analyze data to identify improvement opportunities and initiate actions for improvement · Develop, apply and maintain quality requirements and standards for manufacturing products · Monitor effectiveness of control plans and implement changes as required · Conduct system audits, process audits, and audits related to specific corrective and preventive actions · Provide training as needed to quality personnel and operators · Participate in new product development · Develop and/or participate in IQ, OQ, PQ, and Measurement System Analysis protocols and reports. · Four-year Engineering degree required Knowledge, skills, and abilities desired: · Relevant experience in related industry · Quality Management System experience. Exposure in ISO 9001, AS9100, ISO 13485, or IATF16949 · Knowledge in regulated industries · Problem Solving including experience in Statistical analysis and Lean manufacturing · Experience in Risk evaluation and management · Six Sigma Green Belt or Black Belt · Polymer processing knowledge evaluation · ASQ, CQT or CQE certification