Senior QA Manager Job Atlanta area,Georgia USA,Quality Assurance

Job Description

Who is Cor Dx?

Cor Dx 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, Cor Dx 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

Manage and supervise the QA team's daily activities, ensuring effective execution of quality processes.

Support the implementation and maintenance of the company's QMS, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and other standards.

Collaborate with R&D, Manufacturing, Regulatory Affairs, and Operations to integrate quality requirements into product development and manufacturing.

Lead and support audits, including preparation of documentation and follow-up actions.

Manage non-conformances, CAPAs, complaints, and deviations with timely investigations and root cause analysis.

Assist in regulatory inspections and audits, serving as a key team member.

Monitor regulatory changes and industry trends, advising on necessary updates.

Develop and track quality metrics (KPIs) to monitor QA effectiveness.

Provide training and mentorship to QA staff, fostering continuous improvement.

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.

Cor Dx is an equal opportunity employer committed to diversity and inclusion.

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