New · posted Nov 11
Alcon · Medical Devices
Sr. Associate, Quality Assurance Engineering
- Fort Worth, TX
- On-site
- Full-time
- Senior & Principal
The role
At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?
This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes.
The Sr. Associate, Quality Assurance Engineering (Science/Tech/Engineering Path), is primarily responsible for developing, modifying, and maintaining quality evaluation and control systems, devising inspection methods, and managing product quality risks. You will apply advanced technical knowledge and analytical skills to ensure product precision and reliability.
Specifics include
- 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 Corrective and Preventive Actions (CAPAs), validations, and verifications, and facilitate investigations and CAPAs at third-party suppliers.
- Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training.
- Meet individual job requirements and contribute to overall organizational compliance.
- Commit to continuous improvement and regulatory compliance.
- This position will focus on support of ASPEX production and laboratories.
What you need
WHAT YOU'LL BRING TO ALCON
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs).
- The ability to fluently read, write, understand, and communicate in English.
- 2 Years of Relevant Experience
- Work Location: Onsite
- Travel Requirements: None
- Relocation assistance: No
- Sponsorship available: No
Pay and benefits
Alcon didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
HOW YOU CAN THRIVE AT ALCON
Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
Collaborate with teammates to share standard processes and findings as work evolves!
See your career like never before with focused growth and development opportunities!
Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
Where you'll work
Fort Worth, TXOn-siteOpen in Maps (opens in a new tab)
More jobs in Fort Worth, TXWorking conditions
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Equal opportunity, accessibility and legal noticesAlcon's statements, word for word
ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY
Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US103 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $104,500 | $123,500 | $138,500 |
Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 218 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Alcon's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance5
- Lab testing and methods5
- Collaboration and leadership3
- Documentation and SOPs2
- Investigations and CAPA2
- Quality systems and risk2
- Validation and qualification1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Alcon on Regulatory Jobs
- 20
- Open roles
- 20
- Distinct roles
- 6
- Locations
By discipline
- Quality16 80%
- Regulatory3 15%
- Clinical1 5%
By level
- Associate & Specialist8 40%
- Senior & Principal5 25%
- Director4 20%
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Sr. Associate, Quality Assurance Engineering at Alcon
Applications close December 5.