Quality Assurance Specialist

3 weeks ago


Houston, Texas, United States Alcon Full time

About the Role:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Alcon. As a Quality Assurance Specialist, you will be responsible for leading activities involving routine product inspections, product impact assessments, and non-conformance reporting.

Key Responsibilities:

  • Audit personnel and processes in manufacturing areas to ensure compliance with regulatory requirements.
  • Analyze audit results to identify trends and provide feedback to QA Ops Management and QA team.
  • Participate in Production Triage team as the lead Quality member to provide direction and support on non-conformance process, product impact assessment, and root cause analysis.
  • Ensure non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
  • Perform Product Quarantine activities, including entering product into quarantine, completing quarantine documentation, and reviewing/disposition non-conformance records for quarantine release.
  • Perform real-time Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions.
  • Initiate and lead QA Ops process improvements from start to implementation, including creating/revising procedures using the Change Control process.

Requirements:

  • Bachelor's Degree or Equivalent years of directly related experience.
  • The ability to fluently read, write, understand, and communicate in English.

Work Environment:

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
  • Excellent oral and written communication, organizational, and teamwork skills
  • 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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