Quality Manager

CorDx; California; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance Plan

Retirement Plan

Paid Time Off

Training & Development

Job summary

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

Qualifications

• 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

Responsibilities

• 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.

Skills

Quality management

Regulatory compliance

Medical devices

Communication skills

Problem-solving

Education

Bachelor’s degree in Science or related field

ISO 13485:2016 lead auditor certification

Job description

We 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.

Position: Quality Manager

Location: San Diego(Onsite)

Salary: $100,000- $130,000

Responsibilities

• 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.

Requirements

• 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

Benefits

• Medical Insurance Plan
• Retirement Plan
• Paid Time Off
• Training & Development
  We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service