The Sr. Quality Engineer II will lead the production platform Quality Engineering team and support activities during the overall product life cycle of platforms. The Sr. QE II will support facility and sterility/microbiology teams as a Quality Engineer, improvement projects, and quality issue resolution approvals, CAPAs, process control, incoming, specifications, quality plans and validations.
Provides overall direction and oversight for the day-to-day operations of assigned Quality Engineering team members in the development, maintenance, and compliance of Quality Systems directly related to manufacturing and packaging operations.
Lead, facilitate, and train others in performing evaluations of process quality and performance attributes to identify continuous improvement initiatives related to quality systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products. •
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. •
Provide day-to-day mentoring, assistance and support to platform Sr. Quality Engineers I, Quality Engineers, and Supplier Quality Engineer personnel related to 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. •
Provide Quality assurance inputs and guidance on proposed product, process, and document changes. •
Responsible for providing Quality Engineering oversite and support to facilities and sterility/microbiology. •
Actively participate in and contribute to routine platform-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc. •
Assure there are adequate product and process controls in place for identified CTQ's •
Uses various statistical and non-statistical problem-solving tools as part of analysis
Posting Dates: 11/9/16-11/16/16 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 Minimum: B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.)
Preferred: M.S. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.), Certified Quality Engineer (CQE), English •
Minimum 5 yrs experience in regulated industry for Medical Device or Pharmaceuticals •
Minimum 5 yrs experience in manufacturing environment related to Quality Systems, process controls, auditing, and/or continuous improvement initiatives •
Minimum 5 yrs experience in a team environment with project lead assignments or assignments in a leadership role •
Strong knowledge of cGMP, FDA, ISO regulations, qualification and validation principles. • Knowledge of risk analysis, FMEA, Control Plans, Gage R&R, Statistics and/or process capability • Understanding of LEAN and six sigma principles. • Knowledge of reading and understanding blueprints and technical drawings. • Basic computer competency in Word, Excel, PowerPoint with preferred competency in Minitab, Access and databases. • Effective written and verbal communication skills •
Preferred: 12 yrs experience in medical device or pharmaceutical industry manufacturing environment related to validation and/or product transfer activities,
A little about us:
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs.