Senior QA Engineer, Quality Systems & Compliance

Alcon MX; Houston (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Job summary

Alcon in Houston, TX is seeking a Sr. Associate, Quality Assurance Engineering to develop and maintain QA systems, apply advanced technical knowledge to ensure product precision and reliability, and manage quality risks across production.

The onsite role focuses on applying ISO standards, conducting CAPAs, and collaborating with cross-functional teams to deliver high-quality eye-care products in a fast-paced environment.

Qualifications

• Bachelor’s degree or equivalent in a related field with experience in quality assurance.
• Experience applying ISO 13485 and ISO 14971 in medical device contexts.
• Strong analytical and problem-solving skills with attention to detail.

Responsibilities

• Perform specialized technical tasks and conduct research to optimize project outcomes
• Develop, modify, apply, and maintain quality evaluation and control systems/protocols
• Devise and implement methods and procedures for inspecting, testing, and evaluating product and equipment precision and accuracy
• Design and analyze inspection and testing processes, mechanisms, and equipment
• Conduct quality assurance tests and perform statistical analysis to assess control levels and manage product quality risks
• Undertake root cause analysis of incidents requiring corrective action and ensure corrective measures and deviations meet acceptable reliability standards
• Review and approve investigations, ensuring timely completion of CAPAs, validations, and verifications, and facilitate investigations and CAPAs at third-party suppliers
• Apply ISO 13485 and ISO 14971 principles to ensure compliance and risk management across production processes, equipment/process/test method validation, and technical projects
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training

Skills

Quality Assurance

Statistical Analysis

Root Cause Analysis

GxP Compliance

CAPA

SOP Development

English Communication

Education

Bachelor’s Degree in related field

Job description

Alcon in Houston, TX is seeking a Sr. Associate, Quality Assurance Engineering to develop and maintain QA systems, apply advanced technical knowledge to ensure product precision and reliability, and manage quality risks across production.

The onsite role focuses on applying ISO standards, conducting CAPAs, and collaborating with cross-functional teams to deliver high-quality eye-care products in a fast-paced environment.