Support LIMS masterdata update and improvement projects (site & global), including LIMS change assessment and liaise with global personnel for the change implementation
Support LIMS sample workflow activities and tests, executing system validations, troubleshooting and performing system enhancements.
Support periodic review activities for laboratory equipment/system/methods, including REE, user access and audit trail review Deliver Administrator responsibilities for laboratory equipment/ systems/ methods
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Maintain and continuously improve the QMS in accordance with ISO 9001and applicable regulations in close collaboration with the Gobal QMS team.
Own and manage SOPs, work instructions, and quality records for the manufacturing environment.
In collaboration with Global QMS and Supplier Management team, support internal, supplier, and third-party/notified body audits; manage CAPA arising from audit findings.
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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 Assurance function, responsible to provide technical support for laboratory equipment/ system/methods which including qualification, troubleshooting and improvement activities.Job responsibilities:
• Provide qualification and troubleshooting support for equipment/ systems/methods
• Remediate gaps and drive improvement for laboratory equipment/ systems/methods
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Processing, validating and monitoring a smooth operations of the Technical quality control areas in the supply Chain logistics processes
Execute and support with the Technical audits, system and business development and planning strategies for the future regional logistics centre in the import and export automotive parts business out of the country
Ensuring validation of high quality of part quality control and data management
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Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.
Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
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The Quality Assurance Auditor is responsible for planning, conducting, documenting, and reporting internal quality system audits to ensure compliance with applicable regulatory requirements, international standards, and company procedures. This role supports the effectiveness of the Quality Management System (QMS) through independent assessments, and participation in customer audits, certification audits, and regulatory inspections. The Quality Assurance Auditor partners with cross-functional teams to identify compliance risks, verify corrective actions, and promote continuous improvement across the organization.
Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Quality Ownership – Take shared responsibility for quality metrics within the assigned production area.
Cross-Functional Collaboration – Work closely with production supervisors, product, tooling, process, and maintenance techs, as well as Customer Quality Engineers (CQEs) to drive quality prevention and improvement initiatives.
Data Analysis & Improvement Planning – Track and monitor quality metrics, analyze data trends, and develop action plans for continuous improvement.
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Collaborate with the production team to obtain precheck lists and verify the completion of necessary manufacturing steps for autonomous mobile robots.
Conduct detailed quality control inspections on autonomous mobile robots, including visual inspections, functional tests, and burnout tests to ensure compliance with established specifications, standards, and safety regulations.
Utilize various testing equipment and tools, such as multimeters, oscilloscopes, power supplies, and specialized software, to perform accurate and reliable assessments of product performance and functionality.
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