**Position for shift B**MAIN PURPOSE OF ROLEWorks closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the qualitysystem requirements and achievement of Key Performance Indicators (i.e. NCMR's, MA's, Yield, Cost Reductionprojects, etc.) and support process/product validation activities.Works with Research and Development and Regulatory Affairs personnel (internal or external) to obtained supporton sustaining activities to assure compliance with product and regulatory requirements.Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).**MAIN RESPONSIBILITIES**:- Verify company's adherence to the established Quality System and GMP/ISO standards.- Assist in completion of risk management and risk analysis including FMEA.- Supports technical and statistical investigations concerning optimization and compliance to specification.- Assist in measuring process capability, process controls, and process validation / efforts.- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities- Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process- Completing and Documenting Monthly Quality Data Review- Leading Build At Risk (BAR) Authorizations & Closures- Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality- System and product requirements- Creation and maintenance of Quality Plans and Reports, typically with mentorship from higher level engineering.- Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.- Conducting Advanced Statistical Data Analyses using Minitab typically with mentorship from higher level engineering.- Maintenance/update to Master Validation Plans and Reports.- Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)- Supports activities during preparation and execution of audits (External / Internal)- Perform other duties and responsibilities as assigned by senior management.QUALIFICATIONS- Bachelor Degree in Engineering- 0-3 years of experience.- Knowledge of statistical, data analysis.- Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC),Quality Tools.- Knowledge with control of nonconforming material, corrective and preventive actions.- Knowledge of FDA, GMP, and ISO 13485 regulations.- Intermediate command of English required
