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Quality Engineer Medical Devices Jobs (NOW HIRING)

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Medical, Dental, Holiday, PTO 401K matching Pay: 40.00-44.00 doe Quality Engineer - Medical Devices Provide hands-on quality engineering support for new product development and design changes for ...

Join the growing team of OMEC Medical as a QA/RA Engineer and help shape quality and regulatory ... You'll be instrumental in ensuring innovative devices seamlessly transition from concept to ...

Principal QAE

Charlottesville, VA · On-site

$112K - $136K/yr

Principal Quality Assurance Engineer, Medical Devices QAE Charlottesville, VA 22911 - Hybrid Lead Quality. Solve Complex Problems. Shape Better Medical Devices. We're seeking a Principal Quality ...

Showing results 41-60

Quality Engineer Medical Devices information

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$45K

$84K

$119K

How much do quality engineer medical devices jobs pay per year?

As of Sep 6, 2026, the average yearly pay for quality engineer medical devices in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, 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 products meet regulatory standards and quality requirements throughout their lifecycle. They develop and implement quality control processes, conduct risk assessments, lead investigations into product defects, and work closely with cross-functional teams to ensure compliance with regulations such as FDA and ISO 13485. Their work helps to guarantee the safety, reliability, and effectiveness of medical devices before they reach patients.

How does a quality engineer collaborate with cross-functional teams in the medical device industry?

Quality Engineers in the medical device field work closely with design, manufacturing, and regulatory teams to ensure products meet stringent quality and compliance standards. They participate in design reviews, help develop verification and validation protocols, and support the implementation of corrective actions. Regular communication with production and R&D teams is essential to identify potential risks early and to ensure that quality is built into every stage of product development. This collaborative approach not only improves product safety and efficacy but also streamlines regulatory submissions and audits.

What are the key skills and qualifications needed to thrive as a quality engineer in medical devices, and why are they important?

To thrive as a Quality Engineer in Medical Devices, you typically need a degree in engineering or a related field, combined with knowledge of quality assurance principles and regulatory requirements (such as ISO 13485 and FDA regulations). Familiarity with risk management tools, validation protocols, and quality management systems (QMS), as well as certifications like CQE (Certified Quality Engineer), are highly valuable. Strong analytical thinking, attention to detail, and effective communication skills enable you to identify issues, collaborate with cross-functional teams, and ensure compliance. These competencies are crucial for maintaining product safety, meeting regulatory standards, and supporting a culture of continuous improvement in the medical device industry.

What is the difference between Quality Engineer Medical Devices vs Quality Technician Medical Devices?

AspectQuality Engineer Medical DevicesQuality Technician Medical Devices
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, basic quality certifications
ResponsibilitiesDesigning quality systems, process improvements, root cause analysisInspecting products, conducting tests, recording quality data
Work EnvironmentDesign and development labs, manufacturing plantsManufacturing floors, quality control labs
Employer & Industry UsageMedical device companies, OEMs, suppliersManufacturers, contract labs, quality departments

In summary, Quality Engineer Medical Devices focus on developing quality systems, process improvements, and ensuring compliance, while Quality Technicians primarily perform product inspections and testing. Both roles are essential in maintaining high standards in the medical device industry but differ in scope and responsibilities.

More about Quality Engineer Medical Devices jobs

What cities are hiring for Quality Engineer Medical Devices jobs?

Cities with the most Quality Engineer Medical Devices job openings:

What states have the most Quality Engineer Medical Devices jobs?

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

Infographic showing various Quality Engineer Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Staff DevSecOps Engineer- Medical Devices

Analogdevices

Wilmington, MA

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 18 days ago


Analog Devices rating

8.7

Company rating: 8.7 out of 10

Based on 19 frontline employees who took The Breakroom Quiz

18th of 161 rated electronics manufacturers


Job description

About Analog Devices

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at www.analog.comand on LinkedIn and X.

Staff DevSecOps Engineer- Medical Devices

The Health Solutions Business Unit at Analog Devices is seeking a DevSecOps Engineer to support the development and operation of secure cloud-native platforms for connected medical devices and digital health solutions.

The successful candidate will contribute to the implementation of secure software development practices, cloud security controls, software supply chain security, and regulatory compliance activities throughout the product lifecycle. This role requires strong experience with AWS cloud environments, CI/CD pipelines, application security, and healthcare software platforms, along with deep expertise in HIPAA compliance, healthcare data protection, cloud security, and cybersecurity requirements for FDA-regulated medical devices. The ideal candidate is a hands-on engineer with experience securing modern cloud applications, automating security processes, and supporting regulated software products from development through deployment and post-market operations.

Key Responsibilities

  • Implement and maintain security controls across AWS cloud environments supporting connected medical devices, Software as a Medical Device (SaMD), and digital health solutions.
  • Integrate and manage security capabilities within CI/CD pipelines and Secure Software Development Lifecycle (SSDLC) processes, including secure coding practices, SAST, DAST, SCA, secrets scanning, container security scanning, and Infrastructure-as-Code security validation.
  • Manage software supply chain security activities, including SBOM generation, dependency management, artifact integrity validation, and vulnerability remediation.
  • Configure and maintain identity and access management, authentication, authorization, encryption, key management, and secrets management solutions across cloud and application environments.
  • Design and maintain audit logging, monitoring, and security controls supporting HIPAA compliance and healthcare data protection requirements.
  • Partner with software engineering teams to identify, prioritize, and remediate security vulnerabilities throughout the product lifecycle.
  • Support security risk assessments, penetration testing activities, vulnerability management, incident response, and operational security efforts.
  • Build and maintain security automation capabilities to improve platform security, compliance, and operational efficiency.
  • Support the reliability, availability, monitoring, and operational readiness of cloud-based production systems.

Requirements

  • Bachelor's, Master's, or Ph.D. degree in Cybersecurity, Computer Science, Software Engineering, Computer Engineering, Information Security, or a related technical discipline.
  • 7+ years of experience in DevSecOps, Cloud Security, Security Engineering, Application Security, or related technical roles.
  • Experience supporting software development for healthcare products, medical devices, or digital health solutions within established quality and compliance frameworks.
  • Strong experience securing cloud-native applications and platforms running on AWS.
  • Hands-on experience with AWS services such as ECS, EKS, Lambda, RDS, S3, SQS, Cognito, IAM, KMS, CloudFormation, and related cloud technologies.
  • Experience implementing and managing CI/CD pipelines using GitHub Actions or similar platforms.
  • Experience with security tooling including SAST, DAST, SCA, container security scanning, secrets detection, Infrastructure-as-Code security scanning, and vulnerability management solutions.
  • Strong understanding of application security principles, secure coding practices, authentication, authorization, encryption, secrets management, and key management.
  • Experience with software supply chain security concepts, including SBOM generation, dependency management, artifact signing, and vulnerability remediation.
  • Experience with Infrastructure as Code technologies such as Terraform, CloudFormation, or AWS CDK.
  • Strong understanding of OWASP guidance, cloud security best practices, and secure software development methodologies.
  • Experience with containerized applications and orchestration platforms such as ECS, EKS, Kubernetes, or similar technologies.
  • Experience implementing and supporting HIPAA-compliant cloud environments and healthcare data protection controls.
  • Experience supporting security and compliance programs aligned with frameworks such as ISO 27001, SOC 2, or similar industry standards.
  • Strong analytical, problem-solving, communication, and collaboration skills.

Additional Desired Skills and Qualifications

  • Experience supporting FDA-regulated products and familiarity with IEC 62304, ISO 14971, FDA Cybersecurity Guidance, and related healthcare software development standards.
  • Experience supporting cloud platforms that enable AI-powered or AI-assisted healthcare solutions.
  • Proven track record of successfully delivering secure cloud-based software products and improving security posture through automation and DevSecOps practices.
  • Professional certifications such as CISSP, CSSLP, AWS Security Specialty, Security+, Certified Kubernetes Security Specialist (CKS), or equivalent.

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.

EEO is the Law: Notice of Applicant Rights Under the Law.

Job Req Type: ExperiencedRequired Travel: Yes, 10% of the timeShift Type: 1st Shift/DaysThe expected wage range for a new hire into this position is $134,644 to $201,966.
  • Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.

  • This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.

  • This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.


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About Analog Devices

Sourced by ZipRecruiter

Analog Devices (NASDAQ: ADI) designs and manufactures semiconductor products and solutions. We enable our customers to interpret the world around us by intelligently bridging the physical and digital worlds with unmatched technologies that sense, measure and connect.

Industry

Electrical equipment, appliance, and component manufacturing

Company size

5,001 - 10,000 Employees

Headquarters location

Norwood, MA, US