Quality Engineer II

The Quality Engineer II is responsible for working with the Quality, Manufacturing and MS&T Engineering teams to support activities during the overall product life cycle of the assigned product groups. The QE II will support continuous improvement projects, quality issue resolution, Non-conformances/CAPAs, process controls, product transfers and validations. In some cases, the QE II will be required to lead small to medium size projects and other day to day operational needs. Assist in mentoring and support the efforts of Quality Engineering staff.

Provide Quality Engineering support and guidance to assigned production area(s) and review/approve proposed product, process, and document changes. Supports product transfers and validations through data collection, review and approvals of protocols/reports, etc. Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters within assigned production area(s). Complete GAP analysis against local, global, and industry standards, as needed, and support development/execution of actions to close gaps under minimal guidance. Investigate and/or provide input on non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA) while providing guidance and approval. Will track and trend NC and CAPA data with guidance using various statistical and non-statistical problem-solving tools as part of analysis. Assist with Manufacturing, Engineering, and other Quality functions to create a presence on the production floor to support the production process. Evaluate production processes and systems for conformance to local, global and industry standards/requirements. Support and promote improvement activities for production area(s). Uses various statistical and non-statistical problem-solving tools as part of analysis of data, issues, or improvement opportunities. Actively participate and contribute in routine platform-based meetings and change control activities. Assure compliance with site Quality Systems procedures. 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. 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. Engineering or Physical Sciences (e.g. Chemistry, Physics, etc.),

Minimum 3 yrs experience with B.S. degree in regulated industry for Medical Device, Pharmaceuticals or equivalent.

Minimum of 1 year of experience/involvement in manufacturing environment related to Quality Systems (CAPA, etc), process controls, auditing, and/or continuous improvement initiatives.

Understanding of cGMP and ISO regulations.

Certified Quality Engineer (CQE), or Six Sigma Certification

Experience in project management with project management certification preferred.

Understanding of validation principles, risk analysis, statistics and/or process capability

Understanding of LEAN and six sigma principles with Green Belt certification preferred.


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