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Quality Engineer Medical Device Jobs (NOW HIRING)

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 ... ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Green Belt.

Intellectt INC

Quality Engineer

Plano, TX · On-site

$68K - $89K/yr

We are seeking a detail-oriented and well-rounded Quality Engineer (QE) with experience in the medical device industry. The ideal candidate will support quality systems, validation activities, and ...

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 ...

B&J Medical LLC

Quality Engineer

Kendallville, IN · On-site

$63K - $85K/yr

Quality Engineer B&J Medical is seeking a detail-oriented Quality Engineer to support quality assurance and regulatory compliance within our medical device manufacturing environment. This role is ...

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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.
Manufacturing Engineer-Medical Device

Manufacturing Engineer-Medical Device

BioPharma Consulting JAD Group

Houston, TX

$69K - $89K/yr

Contractor

Posted 27 days ago

Job description

The Manufacturing Engineer Contractor will support the design, validation, implementation, and optimization of manufacturing processes and equipment for ophthalmic medical devices used in cataract and vitreoretinal surgeries. This role is hands-on and highly technical, with a strong focus on equipment validation, statistical process control, and continuous improvement in a regulated medical device manufacturing environment.

Key Responsibilities

  • Lead, execute, document, and manage validation activities (IQ/OQ/PQ) to support the introduction or modification of automated and semi-automated production equipment and processes.
  • Design, develop, validate, and implement manufacturing processes for ophthalmic medical devices.
  • Provide hands-on engineering support for manufacturing equipment before, during, and after release to production.
  • Apply Lean Manufacturing and Six Sigma methodologies to optimize production processes.
  • Implement Continuous Monitoring using Statistical Process Control (SPC) to maintain equipment and processes in a validated state.
  • Perform continuous statistical analysis of Critical Quality Attributes (CQAs) and process indicators to ensure compliance with product specifications (CpK / process capability).
  • Design fixtures and create technical drawings using CAD software (e.g., SolidWorks) to support daily production operations.
  • Develop and maintain standard work instructions and procedures to ensure robust and high-quality manufacturing processes.
  • Promote cross-functional collaboration through clear communication and effective coordination with all departments.

Required Skills & Competencies

  • Medical Device Validation (IQ, OQ, PQ)
  • Statistical Process Control (SPC)
  • Statistical Analysis techniques including:
    • DOE
    • ANOVA
    • Gage R&R
    • T-Test
    • Tolerance Interval Analysis
    • Control Charts
    • Process Capability (CpK)
  • Proficiency with statistical software (Minitab)
  • CAD design experience (SolidWorks or equivalent)
  • Strong technical writing skills
  • Effective public speaking and communication skills

Preferred Skills

  • Manufacturing simulation software experience (FlexSim - preferred, not required)

Requirements

Education & Experience

  • Required:
    • Bachelor's Degree in Engineering or Biomedical Engineering
    • Minimum of 1+ year of professional experience in a Medical Device Manufacturing environment
  • Preferred:
    • Master's Degree in Engineering or Biomedical Engineering

Benefits

  • 12-MONTH CONTRACT

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