

New · posted Nov 4
Alcon · Medical Devices
QA Associate Quality Engineer
- Johns Creek, GA
- On-site
- Full-time
- Associate & Specialist
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 Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Associate I, Quality Operations (Science/Tech/Engineering Path), is primarily responsible for handling complex tasks and contributing to advanced quality management projects in manufacturing and distribution. You will monitor product quality, resolve non-conformances, and maintain documentation while applying scientific and engineering principles to innovate.
In this role, a typical day will include:
- Handle complex tasks and contribute to advanced quality management projects using your expertise and problem-solving skills
- Make significant decisions within your project area to influence outcomes
- Monitor product quality at various stages and resolve non-conformances promptly
- Maintain relevant documentation and records
- Apply scientific and engineering principles to solve problems and innovate
- Actively participates in Production Triage team as the lead Quality member by providing direction and support to the non-conformance process, product quarantine as non-conformances arises. Ensure nonconformance reports are initiated per established requirements, and applicable activities are identified and implemented
- Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/dispositioning non-conformance records for quarantine release and removal of product from quarantine area
- Stay current with advances in the field and take an agile approach to problem-solving by testing, iterating, and refining solutions
- Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
- Audit personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to QA OP’s Management and QA team
- Commit to continuous improvement and compliance with regulatory requirements, meeting individual job requirements and contributing to overall organizational compliance
- Interact in a team environment with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures
- All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
- Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization
- Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations
- Complete all required training and meet individual job requirements to contribute to the overall compliance of the organization
What you need
WHAT YOU’LL BRING TO ALCON
- High School Diploma or Equivalent; bachelor’s degree preferred
- The ability to fluently read, write, understand and communicate in English
- 3 Years of Relevant Experience
- Location: Onsite-Johns Creek, Georgia - JCM
- Schedule: 1st Shift: Monday – Friday, 8:00AM – 5:00PM EST
- Travel Requirements: N/A
- Sponsorship & Relocation: Not Available
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
Collaborate with teammates to share standard processes and learnings as work evolves!
See your career like never before with focused growth and development opportunities!
Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!
Where you'll work
Johns Creek, GAOn-siteOpen in Maps (opens in a new tab)
More jobs in Johns Creek, GAWorking conditions
Alcon Careers
See your impact at alcon.com.careers
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 4, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $81,250 | $86,000 | $96,750 |
Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 83 open Quality Operations & Batch Release 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 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- GMP and compliance9
- Documentation and SOPs8
- Investigations and CAPA4
- Quality systems and risk3
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release 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
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- 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
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- 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
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Alcon on Regulatory Jobs
- 17
- Open roles
- 16
- Distinct roles
- 5
- Locations
By discipline
- Quality14 82%
- Regulatory2 12%
- Clinical1 6%
By level
- Associate & Specialist7 41%
- Senior & Principal4 24%
- Director3 18%
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QA Associate Quality Engineer at Alcon
Applications close November 30.

