Engineer I - QA
The Engineer I - QA 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 creating /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.
•Complaint Closure: Review new files, initiate and perform preliminary investigation within procedural timelines. Perform peer review for file closure to ensure independent review of investigations and quality summaries. Assist with complaint sample in-take and sample testing.
•Tending: Facilitate Customer Complaint meetings as needed, create quality performance slides summary slides, assist with Customer Experience meetings, and provide ad hoc data for different departments as requested.
•Regulatory: Provide regulatory responses for product family specific requests.
Key Performance Indicators:
•Develop Quality System processes that meet corporate, government, and international regulations.
•Timely identification and appropriate response to events and non-conformances on the manufacturing floor.
•Proper prioritization of workload to address risk and meet compliance and quality requirements.
•Recommendation of actions for continuous process improvements, increased product quality, and compliance risk reduction. -Timely placement and removal of components/products on quarantine.
•Completion of all assigned tasks such as audits, testing approvals, initiation of records, etc. in a timely manner.
Engineer I - QA
•B.S. Engineering or Physical Sciences (e.g. Chemistry, Physics)
•No previous experience require
•Preferred: 2 years of relevant experience
QUALITY ASSURANCE AL
Alcon Research, Ltd.
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.
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