At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an Operation Quality Engineer I, supporting our Quality Assurance Team, you will be trusted to 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 at Houston, Texas US.
Key Responsibilities:
- 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.
Minimum Requirements:
- Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
- The ability to fluently read, write, understand and communicate in English
- Work hours: Exempt - Weekend Shift: Friday- Sunday, and every other Thursday 4:00 a.m. - 4:30 p.m.
- Travel Requirements: 0 to 10%
- Relocation assistance: No
- Sponsorship available: No
Preferred Requirements:
- Engineering
- 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
- SAP, Greenbelt, Minitab and MES experience.
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Alcon
relocation assistance
Dec 10, 2024