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Operation Quality Engineer I

Operation Quality Engineer I

AlconHouston, TX, US
Hace 11 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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 lead activities involving routine product inspections, impact assessments, quarantine activities, non-conformance reporting, audits, and procedural updates to ensure compliance with 21CFR820, ISO, and other regulatory standards at our Houston, Texas facility.

Key Responsibilities :

  • Audit personnel and processes in manufacturing areas for compliance with procedures and regulatory requirements (FDA, ISO, etc.).
  • Analyze audit results for trends and provide feedback to QA management and team.
  • Lead the Production Triage team in handling non-conformances, product impact assessments, root cause analysis, and quarantine activities.
  • Ensure non-conformance reports are initiated and activities are properly documented.
  • Perform Product Quarantine activities, including documentation and disposition of non-conforming products.
  • Conduct real-time quality reviews of in-process documentation to support release decisions.
  • Ensure accurate documentation of activities on the production floor.
  • Lead process improvements within QA Operations, including procedure updates via the Change Control process.
  • Collaborate with Operations, Quality Engineering, Compliance, and Engineering teams to improve processes and product quality.
  • Support additional duties as assigned.

Minimum Requirements :

  • Bachelor's Degree or equivalent experience (or high school +8 years; Associate +4 years).
  • Fluent in English reading, writing, and communication.
  • Work hours : Exempt - Weekend shift : Friday-Sunday and every other Thursday, 4 : 00 a.m. - 4 : 30 p.m.
  • Travel : 0-10%.
  • No relocation assistance or sponsorship available.
  • Preferred Requirements :

  • Background in Engineering.
  • At least 2 years of experience in the Medical Device / Pharmaceutical regulated industry.
  • Excellent communication, organizational, and teamwork skills.
  • Proficiency in Microsoft Office Suite.
  • Ability to handle complex issues creatively and diplomatically.
  • Capability to manage multiple tasks with limited supervision.
  • Experience with SAP, Greenbelt, Minitab, and MES systems.
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