Quality Assurance Engineer I
3 weeks ago
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and looking for diverse, talented people to join Alcon and we are looking for a QA Engineer I to join our team in Johns Creek, GA.
Quality Assurance Engineering work focuses on developing, modifying, applying, and maintaining quality evaluation and control systems/protocols including:
Devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designing and analyzing inspection and testing processes, mechanisms, and equipment
Conducting quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks
Undertaking root cause analysis of incidents requiring corrective action
Ensures that corrective measures and deviation meet acceptable reliability standards and that documentation follows requirements in the John's Creek, GA location.
Responsibilities:
The Quality Engineer I will with minimum mentorship work with the Quality and Manufacturing team and support activities during the overall product life cycle of the assigned production platform. The QE will work product transfers, improvement projects, change requests, quality issue resolution, CAPAs, process control, validations, and low risk e-compliance approvals.
Provide Quality Assurance support and mentorship on proposed product, process, and document changes. Actively participate in routine platform-based meetings.
Assure there are adequate products and process controls in place for identified CTQ’s. Will complete GAP analysis against local, global, and industry standards. Will support under minimal mentorship the development of the quality system through GAP analysis results. Uses various statistical and non-statistical problem-solving tools as part of analysis.
Investigate review and approve CAPA process records, while providing mentorship and input on the investigation strategy, corrective actions, and proposed preventive actions associated with each record. Track and trend NCI and CAPA data using various statistical tools as part of analysis.
Provide Quality Assurance input and mentorship on proposed product, process, and document changes. Prepare, develop, and review SOP changes, review and approve validation documents, memos, reports, site risk assessments and other documentation in accordance with Alcon Quality Manual. Provide oversight and approvals on site validations, validation documents, and low risk level e-compliance changes.
Work with Manufacturing, Engineering, and Chemical Production to build a presence on the floor to support in during the production process.
Support and promote improvement activities to lean the process through alignment of procedures reduction of waste, and a review of process with various problem-solving tools as part of analysis. Responsible for the initiation and leadership of small capital project of low risk or high capital/high risk projects under mentorship.
Perform internal and external audits and other duties as requested.
Key Requirements/Minimum Qualifications:
Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
The ability to fluently read, write, understand, and communicate in English
Work hours: M-F, standard
Travel Requirements: none
Relocation assistance: no
Sponsorship available: no
HOW YOU CAN THRIVE AT ALCON:
Collaborate with teammates to share standard processes and takeaways as work evolve. 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, and much more
#LI-DNI
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
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