Senior Quality Manager — Medical Devices & IVD (Onsite SD)

CorDx; California; Presencial; USD 100.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance Plan

Retirement Plan

Paid Time Off

Training & Development

Descripción de la vacante

CorDx is seeking an experienced Quality Manager in San Diego to ensure products and services meet regulatory and customer expectations. You will oversee quality systems, develop processes, and lead audits, CAPA, and supplier qualification.

This role requires strong leadership to drive continuous improvement and compliance across medical devices and IVD equipment. You will manage documentation, participate in audits, and collaborate with cross-functional teams to uphold the highest quality

Formación

• Minimum Bachelor’s degree in Science or related field.
• ISO 13485:2016 lead auditor certification preferred.
• Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
• Strong understanding of quality management principles and practices in the medical device industry.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively in a team environment.
• Demonstrated problem-solving and analytical skills.
• Attention to detail and strong organizational skills.
• Minimum 10 Years experience in Medical devices, Quality Management, Regulatory compliance and ISO standards

Responsabilidades

• Understand customer needs and requirements to develop effective quality control processes
• Devise and review specifications for products or processes
• Set requirements for raw material or intermediate products for suppliers and monitor their compliance
• Ensure adherence to health and safety guidelines as well as legal obligations
• Supervise inspectors, technicians and other staff and provide guidance and feedback
• Oversee all product development procedures to identify deviations from quality standards
• Inspect final output and compare properties to requirements
• Approve the right products or reject defectives
• Keep accurate documentation and perform statistical analysis
• Solicit feedback from customers to assess whether their requirements are met
• Submit detailed reports to appropriate executives
• Implement, 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.

Conocimientos

Quality management

Regulatory compliance

Medical devices

Communication skills

Problem-solving

Educación

Bachelor’s degree in Science or related field

ISO 13485:2016 lead auditor certification

Descripción del empleo

CorDx is seeking an experienced Quality Manager in San Diego to ensure products and services meet regulatory and customer expectations. You will oversee quality systems, develop processes, and lead audits, CAPA, and supplier qualification.

This role requires strong leadership to drive continuous improvement and compliance across medical devices and IVD equipment. You will manage documentation, participate in audits, and collaborate with cross-functional teams to uphold the highest quality