Responsibilities: Responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities. These activities include process validation, defect analysis and corrective action, new product evaluation, performing internal audits to verify compliance with ISO and FDA/QSR Regulations, personnel training, and developing and implementing improved test and measurement techniques. ll employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment. Oversight of various quality systems including, but not limited to, nonconforming material, audits, management review, external standards, and/or document management. Identification of quality issues and resolution support. Review of test protocols and/or process validation protocols and reports. Preparation and analysis of quality data and metrics. Support of internal audits of systems, products, and processes. Preparation and support of external/regulatory audits. Preparation of engineering changes. Provide training and direction to manufacturing and QA personnel. Participate in MRB meetings. Support nonconforming material disposition. CAPA maintenance including investigation support, and/or corrective action ownership. Support quality/manufacturing related improvement efforts. Must be an independent worker, capable of meeting goals and objectives as defined by Management. wareness of practices and processes utilizing current management tools. Requirements: BS Degree in a Technical / an Engineering discipline. Three years minimum experience within a manufacturing environment, with experience in manufacturing, quality, or process engineering preferred. Medical device experience preferred. CQE certification a plus. Must have knowledge of ISO 13485 and FDA/QSR Regulations. Strong computer skills with software applications for Microsoft Windows including Excel, Word and Minitab. Knowledge of Six Sigma and Lean manufacturing preferred. bility to communicate effectively with personnel at all levels both verbally and in writing. CAPA experience is key. udit experience. ISO 13485 experience.