Quality Engineer, Biotechnology

Quality Engineer, Biotechnology

12 Dec 2024
Maryland, Baltimore, 21240 Baltimore USA

Quality Engineer, Biotechnology

Essential functions—essential functions, including how an individual is to perform them and the frequency with which the tasks are performed; the tasks must be part of the job function and truly necessary or required to perform the job. Job duties to include but are not limited to;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).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.  

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