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Remote Quality Engineer Medical Device Jobs (NOW HIRING)

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Be involved in the medical device software design controls activities, in accordance with the FDA ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Lead Quality Engineer

Chicago, IL · On-site +1

$120K - $165K/yr

Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

$120K - $165K/yr

Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Lead Quality Engineer

Redwood City, CA · On-site +1

$120K - $165K/yr

Apply medical device quality system knowledge as part of quality leadership, including but not ... Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote ...

Quality Engineer II

Neenah, WI · On-site +1

$90K - $110K/yr

Working knowledge of FDA requirements associated with medical device design and manufacturing. * Working knowledge of industrial quality engineering, six sigma techniques, and statistical analysis.

Be Seen First

Remote (must live within territory - northern California, Oregon, or Washington) Hire Type ... Proven B2B sales experience (medical device experience preferred but not required) * Experience ...

MES Developer Plano, TX (preferred) or Remote Visa - Usc and Gc (Strong Communication) 1+ year contract A MES Developer to help with new development for a Fortune-500 medical device client's overall ...

Contract Remote QA Testing Engineer Randstad is partnering with an education firm that is looking for a contract remote QA testing engineer (manual and automated testing). This role is responsible ...

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Remote Quality Engineer Medical Device information

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$45K

$84K

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How much do remote quality engineer medical device jobs pay per year?

As of Jun 29, 2026, the average yearly pay for remote quality engineer medical device 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 Remote Quality Engineer in the medical device industry do?

A Remote Quality Engineer in the medical device industry is responsible for ensuring that medical products meet regulatory and quality standards while working from a remote location. Their duties often include reviewing and improving quality processes, conducting audits, analyzing data to identify trends or issues, and ensuring compliance with regulations such as FDA or ISO 13485. They collaborate with cross-functional teams to resolve quality issues and may also be involved in risk management and validation activities. Remote Quality Engineers use digital tools to communicate and manage documentation, making it possible to fulfill their role away from a traditional office or manufacturing environment.

What are the key skills and qualifications needed to thrive as a Remote Quality Engineer in Medical Devices, and why are they important?

To thrive as a Remote Quality Engineer in Medical Devices, you need a solid background in quality assurance, regulatory compliance (such as FDA and ISO 13485), and engineering principles, typically supported by a relevant engineering degree. Proficiency with quality management systems (QMS), document control software, and risk assessment tools is common, and certifications like ASQ CQE are highly valued. Strong attention to detail, effective problem-solving, and clear remote communication skills help ensure compliance and collaboration across distributed teams. These abilities are crucial for maintaining product safety, meeting regulatory standards, and driving continuous improvement in a regulated industry.

How do Remote Quality Engineers in the medical device industry effectively collaborate with cross-functional teams despite working off-site?

Remote Quality Engineers in the medical device sector regularly use digital collaboration tools such as video conferencing, shared documentation platforms, and cloud-based quality management systems to stay connected with design, manufacturing, and regulatory teams. While working remotely poses challenges in terms of immediate access to physical devices and face-to-face communication, frequent virtual meetings and clear documentation help ensure alignment on project goals and compliance requirements. Building strong relationships with on-site team members and proactively seeking feedback are key strategies for maintaining effective collaboration and ensuring product quality.
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What cities are hiring for Remote Quality Engineer Medical Device jobs? Cities with the most Remote Quality Engineer Medical Device job openings:
What are the most commonly searched types of Quality Engineer Medical Device jobs? The most popular types of Quality Engineer Medical Device jobs are:
What states have the most Remote Quality Engineer Medical Device jobs? States with the most job openings for Remote Quality Engineer Medical Device jobs include:
Senior Quality Engineer

Senior Quality Engineer

Tempus

On-site, Remote

Full-time

Posted 20 hours ago


Job description

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

PLEASE NOTE: This is a hybrid role requiring three days a week in the office. Candidates can be based out of our Chicago (Headquarters), New York, or Redwood City locations.

As a Senior Quality Engineer, you will:

  • Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).

  • Lead risk assessments to determine testing strategies.

  • Be involved in the medical device software design controls activities, in accordance with the FDA Quality System Regulation, ISO 13485, GAMP5, Computer System Validation (CSV) standards and FDA guidance, other applicable regulatory requirements, as well as best practices in the software industry.

  • Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.

Responsibilities:

  • Support regulatory compliance of the host system operating with Tempus Medical Device(s).

  • Develop and maintain CSV policies, procedures, templates and work instructions.

  • Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities.

  • Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software.

  • Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports.

  • Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.

  • Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.

  • Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits.

  • Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Qualifications

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.

  • 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)

  • 3+ years experience in Computer System Validation (CSV).

  • Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA (QSR) FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).

  • Knowledge of quality system principles, practices, and standards for the life science industry.

  • Ability to deliver quality outputs without directions or under minimal supervision.

Chicago Pay Range: $90,000-$130,00

NYC/SF Pay Range: $100,000-$150,000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado, Illinois, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

Additionally,for remote roles open to individuals in unincorporated Los Angeles - including remote roles-Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.