Sr QA Engineer I
The Senior Quality Engineer will provide leadership and support activities as applicable during the projects of the assigned new or existing platforms and Quality Systems in support of medical device products. The Sr. QE will utilize project management skillsets in leading and/or supporting Tech Transfers, continuous improvement projects, quality issue resolutions, CAPAs, process control, validations, supplier oversite and other day to day operational needs. Assist in mentoring, assistance and support the efforts of Quality staff.
Interacts effectively with other facilities to support product tech transfer Actively participate & contribute in routine platform-based meetings & change control activities. Assure compliance with site QA Systems procedures Provides guidance and facilitate risk management reviews Review and support validations, product, equipment and manufacturing processes Provide QA support & guidance on medical device products, process, and document changes. Assure there are adequate product & process controls in place for identified CTQ's Initiate & complete GAP analysis against local, global, and industry standards. Continually develop the quality system through GAP analysis results and change control activities. Lead & facilitate training to further support product and process improvement. Review & approval of change control and validation documentation Identifies & drives continuous quality improvement opportunities Provide input & approval on non-conformance incidents, Corrective Actions and Preventive Actions. Track and trend NCI & CAPA using various statistical and non-statistical problem solving tools. Drive the reduction of reoccurring and non-reoccurring events through MRB and IRB. Develop as the subject matter expert for focus areas to support engineering & operations. Uses various statistical and non-statistical problem-solving tools as part of analysis Lead, facilitate, and train others in the execution of risk management processes in compliance with external standards and corporate requirements. Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various statistical and non-statistical problem solving tools as part of analysis. Initiation & leadership of large capital and/or high risk projects. Provide day-to-day mentoring, assistance and support to QEs, Associate QEs, Quality Operations and Supplier Quality personnel related to transfer, validation & qualification concepts & execution, calibration & PM approval, root cause investigations & investigation tools, general process challenges and troubleshooting on the assigned manufacturing platform floor including event identification and quarantine processes, supplier action request. Able to periodically travel EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Minimum: B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.) Preferred: M.S. or higher in Physical Science or Engineering; Six Sigma Black Belt Certification; Certified Quality Eng English •Minimum: 5 yrs experience in regulated industry for Medical Device or Pharmaceuticals; 3 yrs experience in manufacturing quality (quality systems, process controls, auditing, packaging, critical systems, automation, continuous improvement initiatives, etc.). •Thorough knowledge of cGMP and ISO regulations. •Experience in risk analysis, FMEA, Control Plans, Gage R&R, Statistics and CTQ's process capability •Understanding of LEAN and six sigma principles. •Process transfer, scale-up and process improvement experience •Project management experience. •Basic computer competency in Microsoft Office with preferred competency in Minitab, Access, and databases. •Effective written and verbal communication skills. •Preferred: 3 yrs experience in medical device or pharmaceutical industry manufacturing environment related to validation and/or product transfer activities, suppler quality, Operations Excellence or other sustainable improvement programs designed to promote long term organ
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