Operations Quality Engineer I
The Operations Quality Engineer will lead activities involving assigned routine product inspections, product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliance with 21CFR820, ISO, and other regulatory requirements as well as internal requirements.
- Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to QA Ops Management and QA team. - Actively participates in Production Triage team as the lead Quality member by providing direction and support on the non-conformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented. - Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area. - Performs real time Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities. Ensures all required documentation is accounted for and ensures that the documentation is an accurate representation of activities on the production floor. - Initiates and leads QA Ops process improvements from start to implementation including creat-ing/revising procedures using the Change Control process. - Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures. - Lead and/or support other duties as assigned.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment 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. Alcon is 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 protected] and let us know the nature of your request and your contact information 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) with 0-2 years of experience in Medical Device/Pharmaceutical regulated industry English
- Excellent oral and written communication, organizational, and teamwork skills are required
- Proficient in MicroSoft Office (Word, PowerPoint, Excel, etc.)
- Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
- Ability to manage multiple tasks with limited supervision
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