Quality Manager

1 week ago


San Diego, United States CorDx Full time

Quality ManagerWe are looking for an experienced Quality Manager to ensure that our products and services meet all necessary requirements before they reach the consumer. The Quality Manager, or Quality Assurance Manager, will inspect the final product to make sure it has been built with compliance to legal standards and meets customer expectations. A great quality manager is thorough and observant with an eye for detail. They must fully understand the requirements for the product or service and have a sense of responsibility towards our potential and existing customers as well as the competition. The goal is to help preserve our reputation by ensuring that our products and services are capable to drive sustainable growth.Location: San Diego (Onsite)Salary: $100,000- $130,000ResponsibilitiesUnderstand customer needs and requirements to develop effective quality control processesDevise and review specifications for products or processesSet requirements for raw material or intermediate products for suppliers and monitor their complianceEnsure adherence to health and safety guidelines as well as legal obligationsSupervise inspectors, technicians and other staff and provide guidance and feedbackOversee all product development procedures to identify deviations from quality standardsInspect final output and compare properties to requirementsApprove the right products or reject defectivesKeep accurate documentation and perform statistical analysisSolicit feedback from customers to assess whether their requirements are metSubmit detailed reports to appropriate executivesImplement, manage, and improve the company's quality management system, with a primary focus on IVD products and equipment.Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor the implementation of corrective and preventive actions (CAPA).Lead and participate in internal audits and management reviews of the company's quality system as a key member of the quality department.Manage the documentation of the company's quality management system, ensuring compliance with relevant standards and regulations.Oversee the quality management system for IVD equipment, ensuring compliance with applicable regulations and standards.Perform statistical analysis of IVD equipment quality data, prepare reports, and develop corrective and preventive measures as needed.Update company documents in accordance with new or revised quality standards, laws, and regulations.Establish collaborative relationships with key opinion leaders and certification bodies to ensure alignment with industry best practices and regulatory requirements.


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