Quality Engineer (Manufacturing Support)

• Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues
• Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI)
• Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ)
• Ensure compliance of QMS procedures within the Business Unit
• Lead Problem Solving meetings
• Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed
• Drive and implement plant wide quality system improvements
• Participate in the development and improvement of the manufacturing processes for existing and new products
• Coordination of PPAP activities
• Provide functional expertise to other support function on quality related issues
• Manage NCR Process
• Interface with Suppliers for new processes, quality Issues and Process Improvements
• Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved

• Degree in Engineering, Science or equivalent is required
• Minimum of 2 years experience in a QA role
• Good level of technical and analytical skills
• Problem Solving Skills and ability to handle multiple tasks in a fast paced environment
• Capable of working as part of a multi discipline team