Quality Engineer

ESSENTIAL DUTIES AND RESPONSIBILITIES * Formulates and maintains quality assurance objectives and coordinates objectives with production procedures in cooperation with the Manager of QA to maximize product reliability and minimize costs. * Devises sampling procedures, and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data consistent with company policies and procedures. * Works with Materials/Purchasing Department to assure acceptable supplier quality and delivery. * Works with Staff Managers and Sales/Marketing to assess customer satisfaction and address/resolve issues. * Plans, promotes, and organizes training activities related to product quality and reliability. * In conjunction with the Quality Manager, serves as a representative & directs ISO 9001-2008 (ANSI/ASQC Q9001-1994) * Lead product and process risk assessment * Knowledge of SPC, FMEA, MSA, and Control Plan development * Ability to work with team to gather information to write Validation Protocols, Final Reports, Master Plans for Process Validation and Product Qualifications * Conduct data collection, data analysis, and trending * Assist and/or lead in thorough investigations of quality issues and effective corrective and/or preventative action * Lead product scale-up for process capability and statistical relevancy * Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; product quality improvement and root cause analysis EDUCATION and/or EXPERIENCE: * BS in Engineering (Quality or Industrial Preferred) or related field of study * 5+ years of experience in a similar role * Quality management systems experience (ISO 9001) * Experience with PPAP, PFMEA, GD&T