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Quality Assurance Manager Medical Device Jobs (NOW HIRING)

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

$110 - $170/hr

We are seeking a talented and motivated QA Manager, reporting to the Director of Quality Assurance ... Working knowledge of core QMS concepts and medical device standards, including 21 CFR 820, ISO ...

New

... medical device standards. ● Develop, implement, and maintain quality system processes, including procedures for design control, production, process validation, and post-market activities. ● Lead ...

Our client is seeking a Quality Assurance Manager responsible for developing and implementing ... Minimum 5 years proven experience in the medical device industry. Minimum 2 years of experience in ...

Quality Assurance Manager

Clifton, NJ · On-site

$107K/yr

  • Medical

  • Dental

  • Retirement

Prioritized Must Have Skills for the Quality Assurance Manager: #1. 8+ years of quality leadership ... Medical Insurance * Dental Insurance * Retirement About Relevante, Inc. - the Recruiting Firm ...

Senior QA Manager

Atlanta, GA · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Senior QA Manager Location: Atlanta, GA Position Type: 5 days Onsite Exempt Position * Manage and ...

Quality Assurance Manager

Cincinnati, OH · On-site

$120 - $180/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Specific areas of support may include the Document Center, Device QA, Labeling, Validation ... medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to ...

New

Quality Assurance Manager

Cincinnati, OH · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Specific areas of support may include the Document Center, Device QA, Labeling, Validation ... medical/dental/vision insurance and 401(k) to eligible employees.​ * This job is eligible to ...

The QA Manager will be part of Operations, reporting directly to the Business Unit Leader; any conflicts between Operations and Quality will be addressed through the Group Business Unit Leader. * All ...

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Quality Assurance Manager

Orange, TX · On-site

$85K - $95K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Quality Assurance Manager is responsible for leading the quality assurance program at the respective Eagle Railcar Services facility. The Quality Assurance Manager implements and maintains ...

Quality Assurance Manager

Winchester, VA

$75K - $85K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Quality Assurance Manager will report to the Corporate Quality Assurance Manager and is responsible for managing quality assurance and quality control systems to ensure proper execution of ...

Quality Assurance Manager - Job D escription The Quality Assurance Manager ensures all regulatory, customer, and internal quality standards are met. This role leads the QA and Sanitation teams ...

GRIFFIN Recruiters Job Openings >> QA MANAGER QA MANAGER Summary Title: QA MANAGER ID: 1239 Location: Huntsville, AL More about this job > Description Manufacturing QUALITY MANAGER Verify your resume ...

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Quality Assurance Manager Medical Device information

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$24K

$86.2K

$158K

How much do quality assurance manager medical device jobs pay per year?

As of Aug 19, 2026, the average yearly pay for quality assurance manager medical device in the United States is $86,159.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $136,000.00 per year, depending on experience, location, and employer.

What does a quality assurance manager do in the medical device industry?

A Quality Assurance (QA) Manager in the medical device industry is responsible for ensuring that all products meet regulatory standards and company quality requirements throughout their lifecycle. This includes developing and implementing quality management systems, overseeing audits and inspections, and ensuring compliance with regulations such as FDA, ISO 13485, and other relevant standards. The QA Manager also leads efforts to investigate product issues, manages corrective actions, and works closely with cross-functional teams to maintain product safety and efficacy. Their role is critical in preventing defects, reducing risk, and ensuring that medical devices are safe and effective for patients.

What are the key skills and qualifications needed to thrive as a quality assurance manager in the medical device industry?

To thrive as a Quality Assurance Manager in the Medical Device industry, you need strong knowledge of quality systems, regulatory standards (such as ISO 13485 and FDA 21 CFR Part 820), and a relevant degree in engineering or life sciences. Familiarity with risk management tools, CAPA systems, validation protocols, and quality management software is typically required, along with certifications like ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE). Exceptional attention to detail, leadership, problem-solving, and communication skills help ensure compliance and foster a culture of continuous improvement. These competencies are crucial to maintaining product safety, regulatory compliance, and upholding the reputation and success of the organization.

What are some common challenges faced by quality assurance managers in the medical device industry, and how can they be addressed?

Quality Assurance Managers in the medical device industry often encounter challenges such as navigating complex regulatory requirements, ensuring consistent product quality, and managing audits. Staying updated with evolving FDA and ISO standards is crucial, as non-compliance can impact product approval and marketability. Effective communication with cross-functional teams, implementing robust quality systems, and fostering a culture of continuous improvement are key strategies to address these challenges and ensure patient safety.

What is the difference between Quality Assurance Manager Medical Device vs Quality Control Supervisor Medical Device?

AspectQuality Assurance Manager Medical DeviceQuality Control Supervisor Medical Device
CertificationsISO 13485, Six Sigma, CQEISO 13485, Six Sigma, CQE
Work EnvironmentOversees QA processes, audits, complianceSupervises QC testing, inspection, sampling
Employer & Industry UsageManufacturers, regulatory agencies, medical device companiesManufacturers, quality labs, medical device firms

The main difference is that the Quality Assurance Manager Medical Device focuses on establishing and maintaining quality systems, ensuring compliance, and managing audits. In contrast, the Quality Control Supervisor Medical Device primarily oversees testing and inspection of products to detect defects. Both roles require similar certifications and work within the same industry, but their responsibilities differ in scope and focus.

More about Quality Assurance Manager Medical Device jobs

What cities are hiring for Quality Assurance Manager Medical Device jobs?

Cities with the most Quality Assurance Manager Medical Device job openings:

What states have the most Quality Assurance Manager Medical Device jobs?

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What job categories do people searching Quality Assurance Manager Medical Device jobs look for?

The top searched job categories for Quality Assurance Manager Medical Device jobs are:

Infographic showing various Quality Assurance Manager Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $86,159 per year, or $41.4 per hour.

Quality Assurance Manager

CorDx

Alpharetta, GA

Full-time

Medical, Retirement, PTO

Re-posted 25 days ago


Job description

Who is CorDx  
 

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.  
Position: QA Manager
Location: Alpharetta/Chamblee
Position Type: 5 days Onsite Exempt Position

Job Summary: We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have at least 7 years of experience in the IVD industry, with a strong background in quality management systems, regulatory compliance, and team leadership.

Key Responsibilities:

Quality Systems & Compliance

  • Develop, implement, and maintain Quality Management Systems (QMS) in accordance with, US FDA, ISO 13485, and applicable regulations.
  • Lead internal and external audits, regulatory inspections, and corrective action plans (CAPAs).
  • Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity.

Process & Product Quality Assurance

  • Develop and enforce Standard Operating Procedures (SOPs) and best practices to ensure consistent quality across manufacturing operations.
  • Collaborate with R&D, production, and regulatory affairs teams to ensure new products and processes meet quality standards.
  • Monitor and analyze quality metrics (KPIs) to drive continuous improvement initiatives.
  • Ensure adherence to Good Documentation Practices (GDP) and data integrity policies.

Leadership & Team Development

  • Lead, mentor, and develop the QA team, fostering a culture of quality, compliance, and continuous improvement.
  • Train manufacturing and quality teams on quality systems, and root cause analysis (RCA) methodologies.
  • Serve as the primary point of contact for quality-related issues and escalations.

Risk Management & Continuous Improvement

  • Identify quality risks and implement proactive mitigation strategies.
  • Lead investigations and root cause analyses for product defects, deviations, and non-conformances.
  • Drive LEAN, Six Sigma, or other process improvement initiatives to enhance efficiency and reduce waste.
  • Stay updated on industry trends, new regulations, and technological advancements in medical device IVD quality assurance.

Requirements

  • Bachelor's or Master's degree in Biotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  •   7+ years of experience in quality assurance within biotech, pharmaceutical, or medical device manufacturing.
  •  3+ years in a managerial or leadership role overseeing QA teams.
  • Skills & Competencies
  • Strong knowledge of US FDA, ISO 13485, and other regulatory standards.
  • Experience with QA audits, inspections, CAPA investigations, and risk management.
  • Proficiency in QMS software and documentation control systems.
  • Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
  • Excellent leadership, communication, and cross-functional collaboration skills.

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.