As a Senior Quality Engineer- Biotechnology you are responsible for product quality on assigned programs to ensure that customer contract requirements are fulfilled. You will routinely liaise with internal Engineering, Sales, Supply Chain, and Operations departments as well as Field Service. The Sr. Quality Engineer may also interface with customers and potential suppliers. You'll be part of an organization expected to perform by setting an example to the rest of the business.Work cross functionally with Science and Technology, Manufacturing Engineering and Production in providing effective and responsive support to resolve in-house, customer and supplier quality related issues.Perform Corrective and Preventive action management with root cause analysis in order to safeguard the product and the customer experience.Assist in the development, implementation and maintenance of the QMS to ISO9001 including completion of Internal Audits and development of internal processes/procedures.Perform in-process and final assembly inspections, collect and publish results, and conduct feedback sessions for corrective and preventative action.Support the engineering and manufacturing teams to help design and execute the necessary product qualification and validation tests and any necessary analysis and follow-up activities.Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of Production Part Approval Process (PPAP) activities.Conduct product performance analysis and reporting.Drive and implement quality system improvements in alignment with and/or under the direction of the Quality Manager.Lead and participate in problem solving meetings using approved/formal problem-solving tools (8D, PDCA, etc).Lead PFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.Maintain 5S practices. Participate / facilitate in LEAN 6 Sigma events.Support key quality and management system processes such as NCR, CAPA and ECN.Lead training activities on Quality related procedures.Provide functional expertise to other support functions on quality related issues.
