Quality Assurance Engineer

The OfferWork in a growing business with exciting career opportunitiesLeadership RoleFlexible scheduleThe JobYou will be responsible for :Ensuring compliance to Good Manufacturing Practices (GMP).Improving the quality of outputs through continuous improvement of operations (TCM).Improving customer satisfaction by providing accurate and value-added responses to customer concerns and issues in a timely manner.Ensuring strong process quality by driving adherence to acceptable process.Ensuring compliance with ISO 13485 & 9001Managing a team of 6-10 people.Competency to read, verify and / or modify engineering drawins as neededDesign review documentationA thorough knowledge of PDP processComplaint handlingExpert understanding and follow through of CAPA processFMEA requirements and documentationOSHA certificationInternal auditsLeading FDA auditsServe as management representativeIdentifying the root causes of faults or problems by conducting Root Cause Analysis.Inspection and testing of various parts manufacturing, products, components and comparing with predefined standardsImprove written procedures as neededEnhance operational controls for each processThe ProfileYou have at least 7 years experience including solid experience in a similar role within Industrial and Medical deviceYou have working knowledge of FDA regulatory complianceYou pay strong attention to detail and deliver work that is of a high standardYou possess strong analytical skills, are comfortable dealing with numerical data and technical writingYou are a strong mentor who builds high performing teams, supports growth and profitabilityYou are willing to travel once per monthThe EmployerOur client is a world-class manufacturer of medical devices and more specifically spinal orthopedic devices. With a mindset driven toward innovation, Our client is committed to excellence.#J-18808-Ljbffr