Sr. Quality Engineer I (Tech Transfer)
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 projects
Actively participate and contribute in routine platform-based meetings and change control activities.
Assure compliance with site Quality Systems procedures
Provides guidance and facilitate risk management reviews (HAA, FTA, FMEA, ISO 14971)
Review and support validations, product, equipment and manufacturing processes
Provide Quality Assurance support and guidance on medical device products, process, and document changes.
Assure there are adequate product and process controls in place for identified CTQ’s
Initiate and complete GAP analysis against local, global, and industry standards.
Continually develop the quality system through GAP analysis results and change control activities.
Lead and facilitate training to further support product and process improvement.
Review and approval of change control and validation documentation
Identifies and drives continuous quality improvement opportunities
Provide input and approval on non-conformance incidents (NCI) and Corrective Actions and Preventive Actions (CAPA). Track and trend NCI and 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 and 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 (risk identification, mitigation, and controls) 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 and leadership of large capital and/or high risk projects.
Provide day-to-day mentoring, assistance and support to Quality Engineers, Associate Quality Engineers, Quality Operations and Supplier Quality personnel related to transfer, validation and qualification concepts and execution, calibration and PM approval, root cause investigations and investigation tools, general process challenges and troubleshooting on the assigned manufacturing platform floor including event identification and quarantine processes, supplier action request, etc.
Able to periodically travel.
Other: Work with Manufacturing, Engineering, and Quality Operations to create a presence on the floor to support in during the production process. Education of Quality Systems and associated systems for development of skill sets and understandings. Work closely with Quality to ensure smooth transition of Tech Transfer projects to the facility.
Posting Dates: 8/11/16-8/18/16 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 B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc)
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.
M.S. or higher in Physical Science or Engineering; Six Sigma Black Belt Certification; Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)
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 organizational culture change.
Working application experiences related to qualification and validation principles, guidelines and industry practice, FMEA, Risk Analysis, Gage R&R, Statistics, DOE, Measurement Systems Analysis (MSA), and/or process capability. Project and people management with capital projects. The ability to develop people both inter and intra departmentally through open communication and feedback.
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