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The Quality Engineer is responsible to ensure the operations adherence to organization’s Quality Systems. Will develop and maintain quality engineering methodologies, provide quality engineering support within new product development, manufacturing, and supplier quality management activities. Provide work direction for 3-5 Technicians/Inspectors/Auditors.**Experience & Special Skills desired**Bachelor’s degree in Engineering required. Advance degree preferred.2+ years’ experience regulated manufacturing required.Sound knowledge of, and experience implementing, quality systems, approaches, and tools.Knowledge of FMEA, Validations (IQ/OQ/PQ) and sampling strategies.Proficient in Microsoft Office and Minitab.Knowledge in DOE, MSA and SPC.Working knowledge of ISO 13485 and/or 21 CFR 820.Experience in in Product Lifecycle and Change Control management - ECO, DCO.Thorough knowledge and understanding of NPD and manufacturing quality requirements.Solid communication and interpersonal skills.Demonstrated ability to achieve positives outcomes through direct interaction with Customers and SuppliersPrior medical device experience. Preferably Class II or III medical device.Experience in Infinity QS - SPC tool.Experience in ERP system.Experience in facilitating customer/regulatory audits.Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) or Six Sigma certification.Project management and supervisory skills.**Responsibilities**Maintain QMS and be instrumental in assuring all appropriate personnel are in compliance with the QMS.Lead, coach, and mentor non-exempt and entry level personnel.Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.Work with NPD in developing risk analysis documentation - FMEA, Control Plan, and support test method and process validation activities.Design and conduct experiments for process optimization and/or improvement.Participate and support internal stakeholders in Change Order management activities like ECO, DCO for drawing and procedure revisions.Perform and report defects trend analysis, cost of quality, and period quality summaries.Participate in supporting quality disciplines, decisions, and practices. Represent Quality function in Material Review Boards and Complaint Review Boards.Support supplier quality activities, which includes receiving inspections, assessment / selection evaluations, continual support, and SCAR generation throughout satisfactory closeout.Develop strategies and manage data collection & reporting of Key Performance Indicators (KPI’s)Perform other related duties and assignments as assigned.
