We build things that make a difference in people s lives. Our overall company mission is to provide custom precision manufacturing and innovative services to medical, aviation, space, defense and emerging high tech industries. We understand there are lots of choices out there, that is why for over 40 years we have been providing stability, a safe and clean environment, challenging work and are invested in the growth of our people to take them as far as they want to go. Built Right. Every Time. This position is responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all organizational functions, by developing a team atmosphere. Responsible for assuring products/processes conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts to implement company s Quality goals. DUTIES AND RESPONSIBILITIES This position may participate in one or more of the following duties as directed by supervision or management. Evaluating process methods and equipment to meet performance and quality requirements. Monitoring performance of processes to various standards. Establishing quality plans for equipment and processes for general and specific product performance needs. Develop test methods for new specifications and/or equipment. Develops and leads execution of gage, process, and machine capability studies. Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes. Prepares reports by collecting, analyzing, and summarizing data; making recommendations using standard statistical techniques. Apply standard engineering techniques to assigned tasks and ensure that specific goals are met in terms of quality, quantity, and timeliness in order to meet company goals. Applying ISO and QSR requirements to processes and procedures, working with customers and suppliers on new product introduction to insure that quality and performance requirements are fulfilled. Assisting Manufacturing, Sourcing, Business Development in the interpretation and application of regulations. Direct and/or assist both product and process root cause analysis including accountability to initiate, lead and follow through with plans to ultimately resolve these problems. Conduct training on problem solving, including root cause analysis. Write validation protocols, coordinate execution, and write reports for IQs, OQs, and PQs Assist in the development and maintenance of process FMEAs. Other miscellaneous duties as assigned. Responsible to conduct yourself and ensure your subordinates (if applicable) conduct themselves in a manner consistent with company mission, values, code of ethics, policies, and other standards of conduct. EDUCATION/EXPERIENCE BS in Engineering or an alternative Bachelor s degree program Certification as a quality engineer (Eg CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred. 5+ years experience in Engineering, focused in one of the following areas: Quality, Quality Assurance, Manufacturing, Development, Regulatory or Compliance 5+ years FDA or other regulated industry experience required. Six Sigma green belt; black belt preferred. Proven project management experience. Experience working in a batch manufacturing environment a plus. KNOWLEDGE/SKILLS/ABILITIES Experience with deductive and inductive reasoning, in a dynamic manufacturing environment. SPC (Statistical Process Control) Strong written and verbal communicati
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