Sr. Quality Engineer

The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are Youll Do:Provides quality leadership in manufacturing inspection plan leadership to engineering and manufacturing functions for validation planning and NPI transfer activities. Assists teams in determining validation needs and ongoing quality engineering support throughout the product life cycle including CAPA investigations and design changes. Primary quality representative for site supplier management and resolution of supplier nonconformancesSupport internal and external audits to maintain regulatory customer and Avalign Non-Conforming Material Reports system and dispositions all non-conforming and drives product risk management activities. Ensures identified activities and mitigations are executed. Participates in technical discussions and risk-based decision opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement. Establish effective corrective action plans. Lead in implementation of quality assurance plans process controls and CAPA systems designed to meet or exceed internal and external test methods and statistical process control procedures for achieving required levels of product or guides testing and data analysis which demonstrate that new processes meet acceptance criteria including capability studies and Gage R&R as main Quality Engineering contact for assigned customers and supervise quality technicians and/or inspectors as needed at the manufacturing facility. Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures customer requirements; and industry regulations including FDA Quality System Regulation and ISO operations and engineering teams to ensure the Material Review Board process is ongoing quality engineering support to operations including risk management developing appropriate inspection requirements; and complaint/NC/CAPA documentation to customers for new product launches and legacy product documentation Functions: To perform the job successfully an individual should demonstrate the following:Leads assigned team in the development of quality related processes & initiatives. Monitor complaint trends and data in order to escalate emerging issues and implement effective process control systems to support the development qualification and on-going manufacturing of products to meet or exceed internal and external requirementsWhat Youll Need:Candidates should have a BS in an engineering science plus at least 5 years of manufacturing experience or an equivalent combination of education and production introduction/process development experience in a manufacturing environment highly understanding of quality standards (ISO 13485) & regulatory requirements (21CFR820).Ability to read and interpret blueprints as well as have a Knowledge of GD&T and Inspection to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.