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Quality Engineer Medical Device Jobs in Raleigh, NC

Novanta

Sr. Quality Engineer

Apex, NC · On-site

$67K - $91K/yr

We create for our global customers engineered components and sub-systems that deliver extreme ... This position provides a full range of medical, financial, and other benefits to make your quality ...

Novanta, Inc.

Sr. Quality Engineer

Apex, NC · On-site

$67K - $91K/yr

We create for our global customers engineered components and sub-systems that deliver extreme ... This position provides a full range of medical, financial, and other benefits to make your quality ...

Oxford Global Resources

Electrical Engineer

Durham, NC · On-site

... medical device products. You will contribute to various stages of the product lifecycle, from ... and internal quality processes. Job Responsibilities * Design, develop, and test electrical ...

Novanta Inc.

Sr. Quality Engineer

Apex, NC · On-site

$67K - $91K/yr

This position provides a full range of medical, financial, and other benefits to make your quality ... This enables Novanta to engineer proprietary technology solutions that deliver extreme precision ...

Eaton Corporation

Senior Quality Engineer

Middlesex, NC · On-site

$86K - $126K/yr

The Sr. Quality Engineer manages quality assurance resources to ensure product flow consistent with established industry standards, government regulations and customer requirements. Assists the ...

Nutanix

Senior Quality Engineer

Middlesex, NC · On-site

$86K - $126K/yr

The Sr. Quality Engineer manages quality assurance resources to ensure product flow consistent with established industry standards, government regulations and customer requirements. Assists the ...

New

Eaton

Senior Quality Engineer

Middlesex, NC · On-site

$86K - $126K/yr

The Sr. Quality Engineer manages quality assurance resources to ensure product flow consistent with established industry standards, government regulations and customer requirements. Assists the ...

Eaton

Senior Quality Engineer

Middlesex, NC · On-site

$86K - $126K/yr

The Sr. Quality Engineer manages quality assurance resources to ensure product flow consistent with established industry standards, government regulations and customer requirements. Assists the ...

CYNET SYSTEMS

Quality Engineer I

Durham, NC · On-site

$30 - $40/hr

Understanding of quality engineering and manufacturing principles. * Knowledge of root cause ... Medical, Dental, and Vision Insurance * 401(k) Retirement Plan * Health Savings Account (HSA)

Anduril Industries

Product Quality Engineer

Morrisville, NC

$67K - $87K/yr

ABOUT THE JOB As a Product Quality Engineer, you will work inside & outside the organization to define, develop, and execute processes that deliver high quality aerospace structures (composites and ...

Teleflex

Sr. Engineer, Software Dev, R&D

Morrisville, NC · On-site

$114K - $151K/yr

Design and develop medical device software that is high quality, safe, secure and compliant. Lead software developers, third-party designers, vendors, and contractors to deliver high-quality software ...

Teleflex

Sr. Engineer, Software Dev, R&D

Morrisville, NC · On-site

$114K - $151K/yr

... Engineer specializing in Software, you will advance technological innovations in vascular ... medical device software that is high quality, safe, secure and compliant. • Lead software ...

Merz North America

Senior Electrical Engineer

Raleigh, NC · On-site

$95K - $123K/yr

Delivering electrical and embedded products in a timely fashion with integrity and meeting all applicable standard for medical device quality. * Provide electrical and firmware engineering support ...

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All JobsQuality Engineer Medical Device JobsQuality Engineer Medical Device Jobs in Raleigh, NC

Quality Engineer Medical Device information

See Raleigh, NC salary details

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

As of Sep 15, 2026, the average hourly pay for quality engineer medical device in Raleigh, NC is $35.70, according to ZipRecruiter salary data. Most workers in this role earn between $24.09 and $44.62 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 are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

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.

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.

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.

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Quality Engineer Medical Device jobs near you
Infographic showing various Quality Engineer Medical Device job openings in Raleigh, NC as of September 2026, with employment types broken down into 1% As Needed, 74% Full Time, 16% Part Time, and 9% Contract. Highlights an 82% Physical, 1% Hybrid, and 17% Remote job distribution, with an average salary of $74,252 per year, or $35.7 per hour.

Principal Embedded Software Engineer

Raleigh, NC • On-site

Cutera-Inc
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Other

Posted 20 days ago

Job description

Position Summary:We are seeking a highly experienced Principal Embedded Software Engineer to lead the design and development of embedded software for medical device systems. This role focuses on delivering safe, reliable, and high-performance software in compliance with regulatory standards, including ISO 62304.As a key member of our R&D organization, you will translate system requirements into robust embedded software solutions, partnering closely with cross-functional engineering and quality teams. Your work will directly support new product development, design transfer, and lifecycle maintenance of regulated medical devices, ensuring quality, safety, and performance.Duties & Responsibilities:Lead embedded software development activities across the full medical device lifecycle in accordance with ISO 62304.Collaborate with hardware, systems, and quality engineering teams to define system architecture, software requirements, and design specifications.Design, develop, and maintain embedded software primarily in C and C++ for microcontroller and processor-based systems.Participate in requirements definition, risk analysis, and traceability to ensure compliance with regulatory standards.Develop and execute software verification and validation activities, including unit testing, integration testing, and system-level testing.Support design reviews and ensure adherence to design control processes.Contribute to software documentation, including requirements, architecture, design, and test artifacts.Support new product introduction (NPI), design transfer, and sustaining engineering activities.Troubleshoot and resolve software defects across development and production environments.Ensure compliance with applicable regulatory and quality standards through structured development and documentation practices.Other duties as needed or required.Minimum Requirements & Qualifications:Bachelor’s or Master’s degree in Electrical Engineering, Computer Science, or a related field, with 12+ years of experience in embedded software development.Strong experience in medical device software development compliant with ISO 62304.Deep expertise in embedded systems, microprocessor-based controller design and fault finding and resolution.Advanced proficiency in C and C++ for embedded applications.Experience with real-time operating systems (RTOS) and/or bare-metal development.Strong ability to read and interpret electronic schematics and component datasheets.Experience with software verification and validation methodologies in regulated environments.Familiarity with risk management processes (e.g., ISO 14971) and design control practices.Experience working in cross-functional teams including hardware, systems, quality, and manufacturing engineering.Proficiency with debugging tools, version control systems, and embedded development toolchains.Experience supporting product lifecycle activities, including sustaining engineering and post-market support.Preferred Qualifications:Serial communications RS422, SPI, I2C.Closed loop controller (PID) design.Wireless communication (Wi-Fi and cellular).Data encryption.OTA software updates.Embedded graphics development with Qt, LVGL or other framework. #J-18808-Ljbffr

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