Senior QA Engineer - CAPA & Quality Systems Lead

Alcon; Georgia; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Flexible time off

Paid time off

Job summary

Alcon’s Engineering function is seeking a Sr. Associate, Quality Assurance Engineering to develop and maintain quality evaluation and control systems.

The role emphasizes ISO 13485/14971 compliance and risk management across production processes, with responsibilities that include CAPA investigations and statistical analysis. The position is onsite in Houston, TX, on a 1st shift schedule (Mon–Fri, 8:00 AM–5:00 PM CST).

Qualifications

• Bachelor’s degree or equivalent years of directly related experience
• Proficiency in English (written and spoken)
• 2 years of relevant experience
• Onsite location: Houston, TX
• Schedule: 1st shift, Mon–Fri, 8:00 AM–5:00 PM CST
• Travel 0–10%
• Sponsorship & relocation not available

Responsibilities

• Develop, modify, apply, and maintain quality evaluation and control systems and protocols
• Perform inspection, testing, and evaluation of product and equipment precision
• Conduct QA tests and statistical analyses to monitor control levels
• Lead CAPA reviews and ensure timely completion of investigations
• Apply ISO 13485 and ISO 14971 principles for compliance and risk management
• Adhere to GxP SOPs and maintain accurate documentation

Skills

Quality Assurance

Statistical Analysis

Root Cause Analysis

CAPA Management

GxP Compliance

Education

Bachelor’s Degree or Equivalent

Tools

Statistical Analysis Software

Job description

Alcon’s Engineering function is seeking a Sr. Associate, Quality Assurance Engineering to develop and maintain quality evaluation and control systems.

The role emphasizes ISO 13485/14971 compliance and risk management across production processes, with responsibilities that include CAPA investigations and statistical analysis. The position is onsite in Houston, TX, on a 1st shift schedule (Mon–Fri, 8:00 AM–5:00 PM CST).