Senior Quality Assurance Engineer

7 days ago


Lake Forest, California, United States Alcon Full time

**Job Summary**

We are seeking a Senior Quality Assurance Engineer to join our Global Technical Service Quality team in Lake Forest, CA. As a key member of our team, you will be responsible for the development, modification, application, and maintenance of quality standards and processes applicable to Technical Services.

This role collaborates with Global Technical Service, Field Service, Digital Service Operations, and Equipment manufacturing teams to ensure quality standards are in place and applied in respective operational environments. You will primarily support Alcon's Diagnostic Devices and Digital Health Suite of products.

Key Responsibilities:

  • You will serve as a quality engineering subject matter expert within Alcon Global Technical Service organization.

  • Collaborate on the development and refinement of Global Technical Service and Digital Health processes to streamline operations and enhance compliance and operational efficiencies.

  • Evaluate the performance and quality of products to ensure they conform to established standards and agency guidelines resulting in exceptional customer experience.

  • Drive continuous improvement of Technical Service Business and Technical processes.

  • Champion technical investigations of product and process quality issues. Ensure corrective measures comply with applicable standards and support high-level product performance requirements.

  • Lead the development and provide guidance on equipment, process, and software verification and validation.

  • Develop procedures used for inspection and testing of Alcon surgical equipment, sub-assemblies, and related Alcon products.

  • Develop methodologies to measure key product performance, compliance, and other quality metrics for Global Technical Service.

  • Provide support as a subject matter expert for internal audits and external audits and inspections.

Minimum Qualifications:

  • Bachelor's Degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)

  • The ability to fluently read, write, understand, and communicate in English

  • 5 Years of Relevant Industry Experience

  • Work hours: Exempt / Hybrid

  • Travel Requirements: 10% travel Domestic & International

  • Relocation assistance: No

  • Sponsorship available: Yes

Preferred Qualifications/Skills/Experience:

  • 3+ years' experience in Quality Operations/ Manufacturing/ Engineering/ Field Service in relevant GMP industry. Medical Device or Healthcare preferred

  • Experience with Basic Networking, EHR/EMR, DICOM, and cloud technology management

  • Excellent verbal / written communication and customer service skills

  • Proven leadership, project management, effective decision-making capabilities, strong analytical, problem-solving and negotiation skills

  • Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, SharePoint, MS Project, or other Project Management tools



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