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Remote Quality Engineer Medical Device Jobs in Massachusetts

You will also work with cross-functional teams work with developers, Product Managers and Remote QA teams to develop software tests which verify and exercise product requirements. The candidate must ...

QA/RA Consultant

Boston, MA · On-site +1

$130K - $150K/yr

Our ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about ...

Direct experience working on clinical evaluations within the Medical Device industry a plus ... Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering, Research ...

Direct experience working on clinical evaluations within the Medical Device industry a plus ... Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering, Research ...

Key Account Manager, Medical

Boston, MA · On-site +1

$150K - $185K/yr

Remote in the US Travel: 60% domestic How You'll Make an Impact As an Account Manager at Lubrizol ... Develop and execute strategic account plans for targeted medical device customers to drive revenue ...

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Remote Quality Engineer Medical Device information

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.

How does a remote quality engineer 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.

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.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Massachusetts?

The most popular types of Quality Engineer Medical Device jobs in Massachusetts are:

What are popular job titles related to Remote Quality Engineer Medical Device jobs in Massachusetts?

For Remote Quality Engineer Medical Device jobs in Massachusetts, the most frequently searched job titles are:

What job categories do people searching Remote Quality Engineer Medical Device jobs in Massachusetts look for?

The top searched job categories for Remote Quality Engineer Medical Device jobs in Massachusetts are:

What cities in Massachusetts are hiring for Remote Quality Engineer Medical Device jobs?

Cities in Massachusetts with the most Remote Quality Engineer Medical Device job openings:

Infographic showing various Remote Quality Engineer Medical Device job openings in Massachusetts as of August 2026, with employment types broken down into 71% Full Time, and 29% Contract. Highlights an 100% Remote job distribution.

Sr. Software Developer Quality Engineer- Medical Devices

United Airlines

Burlington, MA • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 20 days ago


United Airlines rating

7.9

Company rating: 7.9 out of 10

Based on 343 frontline employees who took The Breakroom Quiz

7th of 26 rated airlines


Job description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's mostinnovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as theyprovide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days arethe same. 

.

Location

Hybrid (minimum 3 days onsite) - Andover, MA OR Remote

About the job you're considering

 

Capgemini Engineering is seeking a Senior Design Quality Engineer- Medical Devices. You will be responsible for ensuring endtoend design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and postmarket activities.

Your role

  • Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
  • Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
  • Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
  • Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
  • Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
  • Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
  • Responsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
  • Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)
.

Your skills and experience

 

  • Bachelor's degree in business, Engineering, Project Management, Computer Science, or a related discipline.
  • 10+ years of experience in software quality assurance within regulated environments (medical device preferred)
  • Should have embedded development/ Digital Platform background Or exposure to embedded development / Digital Platform within Medical Devices domain (preference class II OR III)
  • Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements
  • Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
  • Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
  • Hands-on experience with software verification and validation using risk-based approaches aligned with FDA expectations
  • Familiarity with FDA regulations and standards (e.g., 21 CFR 820, 812, 814).
  • Experience with test management, defect tracking, and quality documentation tools
  • Strong analytical, documentation, and stakeholder communication skills with ability to influence quality decisions

The base compensation range for this role in the posted location is: 68,911 - 150,350

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include: 

  • Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
  • Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
  • Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
  • Life and disability insurance
  • Employee assistance programs
  • Other benefits as provided by local policy and eligibility

Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.

Disclaimers

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. Capgemini also participates in the Partnership Accreditation in Indigenous Relations (PAIR) program which supports meaningful engagement with Indigenous communities across Canada by promoting fairness, accessibility, inclusion and respect.  We value the rich cultural heritage and contributions of Indigenous Peoples and actively work to create a welcoming and respectful environment. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodation does not pose an undue hardship. Capgemini is committed to providing reasonable accommodation during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Click the following link for more information on your rights as an Applicant in the United States.  http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.


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About United Airlines

Sourced by ZipRecruiter

United Airlines is embarking on an exciting journey to become the best airline in aviation history. Our purpose, "Connecting People, Uniting the World," extends beyond transportation, emphasizing our commitment to uplift and create opportunities in the places we serve. With a global presence and diverse workforce, we value inclusivity and are dedicated to hiring tens of thousands of individuals across various roles. Our comprehensive benefits package, including perks like space available travel, parental leave, and 401k, aims to support your well-being and growth.

Industry

Aviation

Company size

10,000+ Employees

Headquarters location

Chicago, IL, US

Year founded

1926

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