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Medical Device Quality Jobs (NOW HIRING)

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

Caraballo Consulting & Associates L

Be Seen First

QA Manufacturing Engineer - Medical Device

Sterling, VA · On-site

$40 - $80/hr

We are seeking a Quality Manufacturing Engineer extensive experience in Medical Devices to oversee Manufacturing Quality projects and line transfers for a Medical Device company. The perfect ...

B. Braun Group

VP, QA Franchise (Med Device)

Allentown, PA · On-site

$260K - $290K/yr

VP, QA Franchise (Med Device) Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Allentown, Pennsylvania, United States Functional Area: Quality Working Model: Hybrid Days of Work: Wednesday ...

Saxon Global

QA ENGINEER

Saint Augustine, FL · On-site

Medical Device Quality Engineer Position Type :Contract Projected Start Date :08-09-2017 Zip Code :33716 City :St. Petersburg State :FL Required Skills : ISO 9000 Not looking for a Design or testing ...

Initial Therapeutics, Inc.

NY · On-site

$126 - $206/hr

Regeneron is currently seeking a Senior Manager, Medical Device Quality Assurance (QA) to join our Medical Device QA team. This expanded leadership role will provide QA oversight across two critical ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · Hybrid

$160K - $180K/yr

You will bridge the gap between rapid Agile development and rigorous medical device regulations ... Design Quality & Risk Management * Design Reviews: Participate in software architecture reviews to ...

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Medical Device Quality information

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How much do medical device quality jobs pay per hour?

As of Sep 2, 2026, the average hourly pay for medical device quality in the United States is $36.72, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $45.91 per hour, depending on experience, location, and employer.

What is medical device quality?

Medical Device Quality refers to the processes and standards used to ensure that medical devices are safe, effective, and comply with regulatory requirements throughout their lifecycle. Professionals in this field oversee quality management systems, conduct inspections, manage documentation, and ensure that products meet both company and government standards. Their work helps prevent defects, maintains patient safety, and supports compliance with agencies like the FDA and ISO standards.

What does a medical device quality professional do?

Professionals in Medical Device Quality are typically responsible for ensuring that products meet regulatory standards and company quality requirements. Daily tasks often include reviewing and updating quality documentation, conducting audits, analyzing data from quality tests, and collaborating with manufacturing and engineering teams to resolve any issues. They also play a key role in managing non-conformances, implementing corrective actions, and supporting continuous improvement initiatives. Regular communication with regulatory bodies and staying updated on compliance requirements are also common aspects of the role.

What are the key skills and qualifications needed to thrive as a medical device quality professional?

To thrive as a Medical Device Quality professional, you need expertise in quality assurance, regulatory compliance (such as FDA and ISO 13485), and strong analytical skills, typically backed by a degree in engineering or a related field. Familiarity with quality management systems (QMS), risk management tools, and validation processes is essential, as are certifications like ASQ CQE or Six Sigma. Attention to detail, problem-solving, and effective communication are critical soft skills for ensuring product safety and collaborating across teams. These competencies help ensure that medical devices meet stringent regulatory standards and maintain patient safety and company reputation.

What is the difference between Medical Device Quality vs Medical Device Regulatory Affairs?

AspectMedical Device QualityMedical Device Regulatory Affairs
CertificationsISO 13485, Six Sigma, CQERegulatory affairs certifications, RAC, ISO 13485 familiarity
Work EnvironmentQuality departments, manufacturing sites, labsRegulatory agencies, corporate offices, compliance teams
Industry UsageEnsures product quality, compliance with standardsManages regulatory submissions, compliance with laws

Medical Device Quality focuses on maintaining product standards and compliance through quality management systems, while Medical Device Regulatory Affairs handles regulatory submissions and ensures products meet legal requirements. Both roles are essential in bringing safe, compliant medical devices to market, but they emphasize different aspects of the product lifecycle.

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What cities are hiring for Medical Device Quality jobs?

Cities with the most Medical Device Quality job openings:

What states have the most Medical Device Quality jobs?

States with the most job openings for Medical Device Quality jobs include:

Medical Device Quality jobs near you
Infographic showing various Medical Device Quality job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.

Quality Engineer Medical Device

Egg Medical Inc

Roseville, MN • On-site

$100K - $115K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 16 days ago

Job description

Summary

We are seeking a Quality Engineer to add to our team! This position will support the management of our quality system while actively contributing to new product design and development initiatives. This role combines core quality engineering responsibilities with technical involvement in engineering projects to ensure our innovative medical devices meet the highest standards of safety, reliability, and regulatory compliance. 

Key Responsibilities

  • Quality System Support: Develop, implement, and maintain elements of the Quality Management System (QMS) to ensure ongoing compliance with FDA regulations, ISO 13485, and other applicable standards.
  • New Product Development & Design Control: Collaborate with R&D, engineering, and cross-functional teams on new design projects; support design inputs/outputs, risk assessments (e.g., FMEA, ISO 14971), design verification and validation activities, and design reviews/transfer to manufacturing.
  • Risk Management & Technical Reviews: Perform and document risk analyses, participate in technical design reviews, and ensure design controls are effectively applied throughout the product lifecycle.
  • Non-Conformance & Corrective Actions: Investigate non-conformances, lead root cause analysis, and implement corrective and preventive actions (CAPA) to drive continuous improvement and prevent recurrence.
  • Documentation & Compliance: Maintain accurate quality records, support internal/external audits, and contribute to regulatory submissions as needed.
  • Continuous Improvement: Identify opportunities to improve quality processes, product designs, and overall efficiency; partner with engineering and other teams on quality initiatives

Qualifications

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Quality Engineering, or a related field.
  • 3+ years of experience as a Quality Engineer in a regulated industry, preferably medical devices.
  • Experience with FDA regulations, ISO 13485, and other medical device quality standards.
  • Proficiency in quality tools and methodologies (e.g., FMEA, SPC, CAPA).

Compensation & Benefits

  • Full-time position with salary range from $100,000-$115,000, depending on experience.
  • Additional bonus/incentive compensation available.
  • Company laptop provided.
  • Insurance available on the 1st of the month following date of hire, including: health, dental and vision insurance, plus pre-tax or Roth 401k available after 30 days.
  • PTO accrues starting at 15 days, plus 11 company paid holidays.

Company Description

Egg Medical is an innovative leader in radiation safety protection technology. Our mission is to protect healthcare professionals from occupational radiation exposure while enabling the delivery of exceptional patient care.