CorDx

Global rapid testing & point-of-care diagnostics

Quality Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSan Diego, CA, USA$100k - $130k

About the Job

Requirements

A minimum Bachelor's degree in Science or a related field is required.
A minimum of 10 years of experience in medical devices, quality management, regulatory compliance, and ISO standards is required.
Thorough knowledge of United States Food and Drug Administration 21 Code of Federal Regulations 820 Quality System Regulation and ISO 13485:2016 standards is required.
A strong understanding of quality management principles and practices in the medical device industry is required.
Excellent communication and interpersonal skills are required.
The ability to work collaboratively in a team environment is required.
Demonstrated problem-solving and analytical skills are required.
Attention to detail and strong organizational skills are required.

Responsibilities

Understand customer needs and requirements to develop effective quality control processes.
Devise and review specifications for products or processes.
Set requirements for raw materials or intermediate products for suppliers and monitor supplier compliance.
Ensure adherence to health and safety guidelines and 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 its properties to requirements.
Approve products or reject defective products.
Maintain 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 in vitro diagnostic products and equipment.
Conduct internal audits, compile audit reports, perform problem analysis, propose improvement initiatives, and monitor implementation of corrective and preventive actions.
Lead and participate in internal audits and management reviews of the company’s quality system as a key member of the quality department.
Manage documentation of the company’s quality management system, ensuring compliance with relevant standards and regulations.
Oversee the quality management system for in vitro diagnostic equipment, ensuring compliance with applicable regulations and standards.
Perform statistical analysis of in vitro diagnostic 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.

Desired Qualifications

ISO 13485:2016 lead auditor certification is preferred.

Quality Manager

CorDx · San Diego, United States · Full-time · Posted 2024-10-23

Salary: USD 100,000–130,000

Workplace: on_site

Department: San Diego

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

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About the Company

CorDx

Global rapid testing & point-of-care diagnostics

CorDx is a multinational biotech organization that provides rapid testing and point-of-care diagnostic devices. Its products are designed to quickly detect infectious diseases (like COVID-19), pregnancy, drugs of abuse, biomarkers, and other health indicators directly at the patient’s side. The devices work by offering fast diagnostic tests and wearable or handheld systems that deliver results on-site, often supported by data science and artificial intelligence to improve accuracy and capture health data. CorDx differentiates itself from competitors through its global reach (2,100+ employees in over 100 countries), scale, and its emphasis on integrating AI and data-driven insights to enhance diagnostic solutions. The company aims to help answer critical health questions by delivering practical, accessible diagnostics and moving toward personalized healthcare.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Atlanta, GA
Founded: 2006

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