Qa Manager
hace 7 días
OverviewThe QA Manager is responsible for leading and maintaining the Quality Management System, ensuring compliance with regulatory standards and customer requirements. This role drives quality strategies, oversees process validation, supports internal and external audits, and ensures the highest quality standards in the manufacturing of medical prescription lenses. The QA Manager will work closely with cross-functional teams to promote continuous improvement and customer satisfaction.QualificationsBachelor’s degree in Engineering or a related field.Minimum of 3 years of experience in a similar QA leadership position.Full proficiency in English, both spoken and written.Experience with quality testing methods.Proven experience in developing and implementing quality strategies.Experience in problem analysis and resolution methodologies.Strong leadership skills with the ability to manage and develop high-performing teams.Excellent judgment and decision-making abilities.Knowledge and experience in process validation (IQ, OQ, PQ, TMV).Certified Internal Auditor or Lead Auditor for ISO 13485.Experience leading and responding to internal and external quality system audits.Experience in customer support and handling quality-related customer issues.Knowledge of Core Tools: MSA, Control Plans, FMEA.Key ResponsibilitiesDevelop, implement, and continuously improve the Quality Management System in compliance with ISO 13485 and applicable regulatory requirements.Lead process validation activities (IQ, OQ, PQ, TMV) to ensure robust and compliant manufacturing processes.Define and execute quality strategies aligned with business objectives and customer expectations.Manage and lead the QA team, promoting a culture of quality, accountability, and continuous improvement.Oversee internal and external audits, including preparation, execution, and follow-up of corrective actions.Ensure compliance with optical and cosmetic specifications and quality standards for medical prescription lenses.Analyze quality data, drive root cause analysis, and implement corrective and preventive actions.Act as the main point of contact for customers on quality-related matters, ensuring timely and effective resolution.Ensure proper documentation, control of records, and compliance with quality procedures.Collaborate with Operations, Engineering, and R&D to support product and process improvements.Recruiting processOur recruitment process may vary; If you are selected, you will be contacted by our recruiters to guide you through the specific steps for your application.Diversity, Equity and InclusionWe are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique. #J-18808-Ljbffr
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