Senior QA Engineer - Quality Systems & Process Validation

alcon; Houston (TX); Sur place; USD 70 000 - 95 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement plan

Flexible time off

Paid time off for hourly associates

Résumé du poste

Alcon is seeking a Sr. Associate Quality Assurance Engineering to develop and maintain quality evaluation systems. You will apply advanced QA techniques to ensure product accuracy and reliability, conduct root-cause analyses, and manage CAPAs across production and suppliers.

Strong technical knowledge and communication in English are essential. Location is onsite in Houston, TX with a Monday–Friday 8:00 AM–5:00 PM schedule.

Qualifications

• Bachelor’s degree or equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; MS.+0 yrs)
• Fluent in reading, writing, understanding and communicating in English
• Minimum 2 years of relevant experience

Responsabilités

• Develop, modify, apply, and maintain quality evaluation and control systems/protocols.
• Design and analyze inspection and testing processes, mechanisms, and equipment.
• Conduct QA tests and statistical analyses to assess control levels and manage product quality risks.
• Perform root cause analysis of incidents and ensure CAPAs and deviations meet reliability standards.
• Review and approve investigations and ensure timely completion of CAPAs, validations, and verifications, including third-party supplier involvement.
• Apply ISO 13485 and ISO 14971 principles to ensure compliance across production processes.
• Follow SOPs, maintain documentation, and support regulatory and quality commitments.

Connaissances

Quality Assurance

Statistical Analysis

English Proficiency

Formation

Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; MS.+0 yrs)

Outils

ISO 13485

ISO 14971

SOPs

Description du poste

Alcon is seeking a Sr. Associate Quality Assurance Engineering to develop and maintain quality evaluation systems. You will apply advanced QA techniques to ensure product accuracy and reliability, conduct root-cause analyses, and manage CAPAs across production and suppliers.

Strong technical knowledge and communication in English are essential. Location is onsite in Houston, TX with a Monday–Friday 8:00 AM–5:00 PM schedule.