Sr Quality Engineer

Alcon; Lake Forest (CA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

A global medical technology company is seeking a Senior Quality Engineer to join their Global Technical Service Quality team in Lake Forest, California. The role involves ensuring quality standards for products, collaborating with various teams on process efficiencies, and driving continuous improvements. Candidates must have 5 years of relevant experience, a Bachelor's Degree, and strong skills in quality engineering and communication. The position is exempt with a hybrid work model and some travel requirements.

Qualifications

• 5 years of relevant industry experience required.
• Ability to communicate fluently in English.
• Experience in GMP industry, preferably in Medical Device or Healthcare.

Responsibilities

• Serve as quality engineering expert within the organization.
• Collaborate to refine processes for operational efficiencies.
• Ensure product performance conforms to established standards.
• Drive continuous improvement of Technical Service processes.
• Lead technical investigations of quality issues.

Skills

Quality engineering expertise

Excellent communication skills

Analytical problem solving

Leadership

Education

Bachelor's Degree or equivalent experience

Tools

MS Office

Project Management tools

Job description

Sr Quality Engineer

Alcon is looking to hire a Sr. Quality Engineer to join our Global Technical Service Quality team in Lake Forest, CA. You will be responsible for 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. This position will primarily support Alcon's Diagnostic Devices and Digital Health Suite of products.

Key Responsibilities

• Quality engineering subject matter expert within Alcon Global Technical Service organization.
• Collaborates on development and refinement of Global Technical Service and Digital Health processes to streamline operations and enhance compliance and operational efficiencies.
• Ensures performance and quality of products conform to established standards and agency guidelines resulting in exceptional customer experience.
• Drives continuous improvement of Technical Service Business and Technical processes.
• Champions technical investigations of product and process quality issues. Ensures corrective measures comply with applicable standards and support high-level product performance requirements.
• Leads development and provides guidance on equipment, process, and software verification and validation.
• Devises, qualifies, and implements procedures used for inspection and testing of Alcon surgical equipment, sub-assemblies, and related Alcon products.
• Develops methodology to measure key product performance, compliance, and other quality metrics for Global Technical Service.
• Provides support as 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.