Quality Engineer

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Responsibilities not listed.

• Quality or Engineering positions
• At least 2 years of experience in Quality or Engineering positions.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Knowledge of statistical/data analysis and report writing experience.
• Experience working on FDA, GMP, and ISO 13485 Regulated environments.
• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
• Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
• Knowledge on product and process qualification and validation.

• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Assist in completion of risk management and risk analysis including FMEA.
• Work with R&D/Design verification and design validation plans for products based on performance specification and risk analysis.
• Supports technical and statistical investigations concerning optimization and compliance to specification.
• Owner of 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, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering.
• 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 minor mentorship from higher level engineering.
• Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minor mentorship from higher level engineering.
• Conducting Statistical Data Analyses using Minitab typically with mentorship from higher level engineering.
• Maintenance/update Master Validation Plans and Reports.
• Supports activities during preparation and execution of audits (External / Internal).
• Perform supervisor activities to Quality Technicians, if required.

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