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Quality Engineer Medical Device Jobs (NOW HIRING)

IT MINDS L.L.C.

Quality Engineer - Medical Device

Newark, DE · On-site

$70K - $90K/yr

Quality Engineer - Medical Device Location: Delaware Largescale Medical Device client facing a remediation project here on site in Delaware. What is the project the contractor will be working on? • ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Medical Device Quality Engineer Location: Madison, WI Pay Rate : $40--45/hr on W2 Schedule: Onsite, Monday-Friday (standard business hours) Summary The Senior Quality Analyst/Engineer is responsible ...

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Quality Engineer Medical Device information

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How much do quality engineer medical device jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for quality engineer medical device 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 does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in the medical device industry, and why are they important?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

What Does a Quality Engineer for Medical Devices Do?

As a quality engineer for medical devices, you oversee the continual improvement of medical devices as well as the design and manufacturing of new devices. Your duties are to develop prototypes, assess the quality of manufacturing standards, and develop guidelines for technological improvement. You also work closely with medical device engineers to ensure sufficient documentation and standardization, which helps users and service technicians test and maintain the safety of devices. Your responsibilities as a medical device quality engineer relate to all aspects of the product life cycle, from prototyping to the supply chain to production.

How does a Quality Engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.
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Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in the United States as of May 2026, with employment types broken down into 2% Locum Tenens, 5% As Needed, 32% Full Time, 52% Part Time, and 9% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $76,384 per year, or $36.7 per hour.
Quality Engineer Medical Device

Quality Engineer Medical Device

Egg Medical Inc

Roseville, MN • On-site

$100K - $115K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 20 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.