Senior QA Manager

CorDx; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, vision insurance

401(k) with company contributions

Flexible PTO

Additional benefits

Job summary

A leading biotech organization is seeking a Senior QA Manager in Atlanta, GA. The role involves managing the QA team, ensuring compliance with regulatory standards, and collaborating with various departments to integrate quality requirements. Candidates should have extensive experience in QA within regulated environments and possess strong leadership skills. The company offers competitive compensation and a range of benefits, including medical insurance and flexible PTO.

Qualifications

• 7+ years in QA within IVD, medical devices, or regulated life sciences.
• At least 3 years in a leadership role.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and international standards.

Responsibilities

• Manage and supervise the QA team's daily activities.
• Support the implementation and maintenance of the company's QMS.
• Lead and support audits, including preparation of documentation.

Skills

Problem-solving

Root cause analysis

Quality tools

Education

Bachelor's in a scientific, engineering, or related technical field

Master's degree or certifications

Job description

Job Description

Who is CorDx?

CorDx is a multinational biotech organization focused on innovation and supply in global health. With over 2,100 employees worldwide, serving millions in over 100 countries, CorDx provides rapid testing and point-of-care medical devices for infectious diseases such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The company is at the forefront of technology, artificial intelligence, and data science, aiming to deliver diagnostic solutions for critical healthcare questions.

Position: Senior QA Manager

Location: Atlanta, GA

Position Type: 5 days Onsite, Exempt

Responsibilities

1. Manage and supervise the QA team's daily activities, ensuring effective execution of quality processes.
2. Support the implementation and maintenance of the company's QMS, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other standards.
3. Collaborate with R&D, Manufacturing, Regulatory Affairs, and Operations to integrate quality requirements into product development and manufacturing.
4. Lead and support audits, including preparation of documentation and follow-up actions.
5. Manage non-conformances, CAPAs, complaints, and deviations with timely investigations and root cause analysis.
6. Assist in regulatory inspections and audits, serving as a key team member.
7. Monitor regulatory changes and industry trends, advising on necessary updates.
8. Develop and track quality metrics (KPIs) to monitor QA effectiveness.
9. Provide training and mentorship to QA staff, fostering continuous improvement.
10. Support risk management activities.

Requirements

Education:

• Bachelor's in a scientific, engineering, or related technical field required.
• Master's degree or certifications preferred.

Experience:

• 7+ years in QA within IVD, medical devices, or regulated life sciences.
• At least 3 years in a leadership role.

Regulatory Knowledge:

• Knowledge of FDA 21 CFR Part 820, ISO 13485, and international standards.
• Experience supporting audits and inspections.

Leadership & Collaboration:

• Ability to supervise, mentor, and collaborate effectively.

Technical Skills:

• Proficient in problem-solving, root cause analysis, and quality tools.

Certifications:

• ASQ certifications preferred.

Attributes:

• Strong organizational skills, capable of managing multiple projects.

Benefits

• Competitive compensation.
• Medical, dental, vision insurance.
• 401(k) with company contributions.
• Flexible PTO.
• Additional benefits.

CorDx is an equal opportunity employer committed to diversity and inclusion.