Alcon
Medical Device
AssociateII,QualityAssuranceEngineering(Science/Tech/EngineeringPath)
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“Associate II, Quality Assurance Engineering (Science/Tech/Engineering Path) at Alcon. Skills: Quality Assurance Engineering, Computerized system validation, Root cause analysis. Develop quality evaluation systems. Maintain quality control systems”
What You'll Achieve.
Ensure reliability standards; Ensure process control; Mitigate risks; Deliver brilliant outcomes
Industry & Context.
Apply advanced technical knowledge; Problem-solving skills
What They're Looking For.
Must Have
Bachelor’s degree in Engineering or Science, Hands-on experience with PLC, Hands-on experience with HMI, Hands-on experience with SCADA systems, understanding of quality systems, understanding of compliance requirements, Good command of English (spoken and written)
Nice to Have
Electrical Engineering is preferred, 1–2 years of relevant experience is an advantage, technical knowledge in automation systems, Experience with packaging machines is a plus
What You'll Do.
Develop quality evaluation systems
Maintain quality control systems
Perform root cause analysis
Design inspection processes
Improve testing processes
Ensure process control
Lead corrective actions
Approve investigations
Approve verifications
Support investigations
Lead corrective actions
Perform system GAP assessments
Improve validation processes
Support digitalization
Lead change management
Support change management
Provide quality oversight
Ensure lifecycle compliance
Support compliance programs
Partner with manufacturing
Drive process improvements
How You'll Work.
Team & Collaboration
Collaborate with cross-functional teams; Partner with manufacturing teams
Communication Scope
Good command of English (spoken and written)
Process & Methodology
Lead corrective and preventive actions (CAPA), Lead or support change management activities
Full Job Description
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 Associate II, Quality Assurance Engineering (Science/Tech/Engineering Path), is primarily responsible for developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analysis to ensure reliability standards. You will apply advanced technical knowledge and problem-solving skills. Specifics Include: * Develop, implement, and maintain quality evaluation and control systems and protocols * Design and improve inspection, testing, and evaluation processes for products and equipment * Conduct quality assurance testing and statistical analysis to ensure process control and mitigate risks * Perform root cause analysis and lead corrective and preventive actions (CAPA) * Review and approve investigations, CAPAs, validations, and verifications * Ensure compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements * Support or lead non-conformance investigations and corrective actions * Execute and approve computerized system validation (CSV) and qualification activities * Apply risk-based validation approaches and perform system GAP assessments * Collaborate with cross-functional teams on CSV and data integrity (DI) initiatives * Develop and improve SOPs, guidelines, and validation processes * Support digitalization and global e-compliance initiatives * Lead or support change management activi
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