Job Description

Support product and service quality evaluation and control within the Specimen Acquisition Group (blood collection products) Work cross-functionally with manufacturing, process engineers, and quality teams Investigate production and equipment-related issues and support root cause analysis (Fishbone Diagram, etc.) Perform complaint support and remediation activities, including: – Reviewing complaint database and identifying manufacturing origin– Ensuring accurate coding and documentation of complaints– Coordinating with production and engineering teams to investigate defects– Driving corrective actions and remediation efforts Analyze nonconformities and identify trends alongside quality engineering teams Utilize systems such as TrackWise (training provided) and SAP for documentation Write test protocols, execute testing, collect/analyze data, and generate validation reports Apply statistical analysis and metrics to evaluate processes and systems Support validation activities for equipment, processes, materials, and methods Ensure compliance with regulatory requirements (cGMP, FDA, ISO) Participate in supplier quality and supplier corrective action process Improve supplier product and process quality Determine root cause and corrective actions Investigate root cause and corrective actions Resolve supplier quality related issues Manage corrective action and quality improvement activities Perform root cause analysis of product quality issues Determine root cause and corrective action plans Implement and verify corrective actions of supplier quality issues Resolving customer quality issues and driving root cause and corrective action on process and product quality issues Obtain corrective actions from suppliers Accomplish internal quality system audits Identify root cause analysis and establish corrective actions Manage the supplier corrective action report Conduct internal quality process and product audits Improve product quality and manufacturing processes Identify repeat quality issues by supplier and maintain supplier quality scorecard Assist supplier quality manager with supplier improvement process and/or development activities Lead or assist in root cause corrective actions Lead quality problem solving process for supplier related issues Bachelor’s Degree required (preferably in Engineering or related field) 6 months to 2.5 years of experience in a highly regulated environment (cGMP, FDA, ISO) Strong experience with Microsoft Excel (macros preferred) Experience with TrackWise (or willingness to learn); SAP and Minitab preferred Knowledge of root cause analysis tools (Fishbone Diagram, etc.) Strong data analysis and statistical skills Excellent communication and collaboration skills Ability to work onsite and follow PPE requirements

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