The Lead Quality Engineer will lead a Quality Engineering team and support activities during the overall product life cycle of the assigned production platform. The Lead QSE will support product transfers, improvement projects, quality issue resolution, CAPAs, process control and validations.
Provides overall direction and oversight for the day-to-day operations of assigned quality 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 Quality Engineers, Associate Quality Engineers, Senior Quality Engineer, 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. Provide Quality assurance inputs and guidance on proposed product, process, and document changes. 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 CTQs. Uses various statistical and non-statistical problem-solving tools as part of analysis. Provides Quality representation and approvals at the Global Change Review Board for global change requests within the respective product areas.
Acceptability of protocols, studies, and validation documents. Final metrics reporting and interpretation. Acceptability of identified deliverables for assigned change controls and documentation reviews. Workload assignments for assigned staff. Achievement of related organizational goals and department objectives.
We are proud to have some of the most exciting manufacturing technologies available. Our facility manufactures more contact lenses than any other site globally. To meet the demands of our customers, a 24/7 operation is required. As such, we must support and or cover weekend and night shifts. Alcon reserves the right to make shift assignments to meet the needs of the business.
As an Alcon associate, you are expected to know, understand, and comply with all applicable safety and health standards and rules.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Alcon participates in E-Verify and our policies are not to discriminate in recruitment, hiring, training, promotion or 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. The Novartis Group of Companies are also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to email@example.com and let us know the nature of your request and your contact information.
Occupational Demand Requirements: Position may involve sitting, walking, standing, seeing, talking, squatting, climbing, reaching, keying, hearing, twisting, bending, kneeling or handling. Position may involve lifting, carrying or pushing less than 50 pounds. Position may involve reading, speaking, writing, reasoning, calculating, or analyzing. Position is predominately indoors.
NO RELOCATION 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.) English 5 years directly related experience.
5 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. A certified non-conformance investigator and/or approver.
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.