Operation Quality Engineer I

Alcon • Houston, TX

313d

About The Position

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 you will be conducting audits of personnel and process in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.) at our facility HOUSTON, TEXAS, (US). In this role, a typical day will include: 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 nonconformance 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/MRB, 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.

Requirements

• Bachelor’s Degree or equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs) – preferably in Biomedical Engineering/Medical Device Development.
• Fluency in reading, writing, understanding, and communicating in English.
• Excellent oral and written communication, organizational, and teamwork skills.
• Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.), TEAMS, SAP.
• Ability to work through complex issues creatively and diplomatically.
• Ability to manage multiple tasks with limited supervision.
• 2 Years of relevant experience.

Nice To Haves

• Process Audit experience
• Root Cause analysis knowledge

Responsibilities

• Conduct audits of personnel and processes in manufacturing areas for compliance with procedures and regulatory requirements (FDA, ISO).
• Analyze audit results for trends and provide feedback to QA Ops Management and QA team.
• Participate in Production Triage team as the lead Quality member, providing direction and support on nonconformance processes.
• Ensure non-conformance reports are initiated and applicable activities are identified and implemented.
• Perform Product Quarantine activities, including documentation and review of non-conformance records.
• Conduct real-time Quality review of in-process documentation to support QA release decisions.
• Ensure all required documentation is accurate and complete.
• Initiate and lead QA Ops process improvements, including creating/revising procedures using Change Control.
• Collaborate with Operations, Quality Engineering, Compliance, and Engineering personnel to improve processes and product quality.

Benefits

• Health insurance
• Life insurance
• Retirement plan
• Flexible time off for exempt associates
• PTO for hourly associates
• Robust benefits package including various health and wellness programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree