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Design Quality Assurance Jobs (NOW HIRING)

Technical Assurance and Review * Establish and oversee design review, checking, verification, and ... Quality Management * Develop and implement project-specific Design Quality Management Plans (DQMPs)

Design manual tests to confirm that the front end build is achieving the desired results and is ... Oversee a team of Jr. QA testers, assigning work, reviewing results and planning out daily tasks ...

Design Quality Engineer

Bedford, MA ยท On-site

$103K - $163K/yr

Job Title Design Quality Engineer The Design Quality Engineer is accountable for design quality ... on Design Assurance, Sustaining and Post Market Complaint investigations. * You have proven ...

Sr. Design Quality Engineer

Wilmington, MA ยท On-site

$96K - $131K/yr

Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures. * Support the development, maintenance ...

Sr. Design Quality Engineer

Wilmington, MA ยท Hybrid

$96K - $131K/yr

Execute quality assurance activities throughout product design and development in accordance with applicable regulations, standards, and company procedures. * Support the development, maintenance ...

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Design Quality Assurance information

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How much do design quality assurance jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for design quality assurance in the United States is $43.83, according to ZipRecruiter salary data. Most workers in this role earn between $38.70 and $47.84 per hour, depending on experience, location, and employer.

What are some common challenges faced by professionals in design quality assurance, and how can they be addressed?

Professionals in Design Quality Assurance often encounter challenges such as balancing strict regulatory requirements with innovative design objectives, ensuring effective communication between design and engineering teams, and keeping up with evolving industry standards. Addressing these challenges typically involves developing strong cross-functional collaboration skills, staying updated on relevant regulations, and implementing robust documentation and testing processes. Proactively engaging with stakeholders early in the design process can also help identify potential issues and streamline quality assurance efforts.

What is the difference between Design Quality Assurance vs Design Engineer?

AspectDesign Quality AssuranceDesign Engineer
Primary FocusEnsuring design quality, standards, and complianceCreating and developing design solutions and prototypes
ResponsibilitiesReviewing designs, testing, quality checksDesigning, drafting, and engineering new products
Required SkillsAttention to detail, quality control, testing methodsTechnical design, CAD skills, innovation
Work EnvironmentQuality assurance teams, testing labsDesign studios, engineering departments

Design Quality Assurance focuses on verifying and maintaining the quality of designs, while Design Engineers are responsible for creating and developing those designs. Both roles are essential in the product development process but serve different functions within the industry.

What is Design Quality Assurance?

Design Quality Assurance (DQA) is a process used to ensure that the design phase of a product or system meets specified quality standards and requirements. DQA involves systematic planning, review, and testing to identify and resolve design issues early, reducing the risk of problems later in development or production. Professionals in this field work closely with designers and engineers to verify that designs are functional, safe, and compliant with industry regulations. Their goal is to deliver reliable, high-quality products to customers by preventing defects from the outset.

What are the key skills and qualifications needed to thrive as a design quality assurance professional, and why are they important?

To thrive as a Design Quality Assurance professional, you need a solid background in engineering or a related technical field, knowledge of quality standards (such as ISO 9001), and experience in product design processes. Familiarity with quality management systems (QMS), root cause analysis tools, and regulatory compliance software is typically required. Attention to detail, problem-solving abilities, and strong communication skills help you effectively collaborate across teams and ensure design integrity. These competencies are essential for minimizing defects, meeting regulatory requirements, and ensuring products are safe and reliable.
More about Design Quality Assurance jobs
What cities are hiring for Design Quality Assurance jobs? Cities with the most Design Quality Assurance job openings:

Staff Design Quality Assurance Engineer (Hybrid - San Diego, CA)

Insulet Corporation

Acton, MA โ€ข Hybrid

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 27 days ago


Job description

Job Summary

The Staff Design Quality Assurance Engineer is a senior quality leader responsible for ensuring compliant design controls, risk management, and verification & validation activities across the full medical device development lifecycle, including system, hardware, and software products. The role partners closely with cross-functional teams to embed quality throughout development, drive regulatory compliance, improve processes, and lead continuous improvement initiatives. Ideal candidates bring 8+ years of medical device quality experience, deep expertise in FDA and ISO standards, strong leadership and stakeholder management skills, and a proven ability to influence product quality and process excellence in a regulated environment.

Position Overview:
This position leads Design Quality Assurance (DQA) and Quality Engineering activities across the full product development lifecycle for medical devices, including system, hardware, and software components, as well as supporting quality system processes and automated tools. The role ensures compliant and efficient execution of design controls in alignment with applicable regulations, standards, and internal procedures, while driving continuous improvement to enhance product quality, process effectiveness, and scalability.

The Staff DQA Engineeris responsible forintegrating design controls, system-level risk management, and verification and validation (V&V) into a cohesive, end-to-end framework with clear traceability and technical rigor. This role serves as a subject matter expert, partnering cross-functionally with R&D, Systems Engineering, Hardware and Software Engineering, IT/Cybersecurity (as applicable), Manufacturing, Human Factors, Regulatory Affairs, and external stakeholders to embed quality early in development and ensure successful product realization and lifecycle management.

Responsibilities:

  • Lead Design Control and Quality Engineering activities for FDA Class II and III medical devices, ensuring complete and compliant Design History File (DHF) documentation acrosssystem, hardware, and software.

  • Ensure compliance with applicable regulations and standards (e.g., FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC standards) while embedding quality throughout the product development lifecycle.

  • Drive integrated system-level risk management, ensuring end-to-end traceability from hazards through risk controls to verification and validation across all product domains.

  • Provide subject matterexpertisein design controls, risk management, system requirements, architecture, and V&V strategies, including hardware, software, and system integration testing.

  • Review and provide high-quality feedback on requirements, specifications, design documentation, risk management files, validation protocols, test plans, and reports.

  • Partner cross-functionally with Engineering and Project Management to ensure effective design control execution and early embedding of quality.

  • Establish, standardize, and continuously improve design control, risk management, and quality processes-driving simplification, harmonization, and efficiency across teams.

  • Identifysystemic gaps andinefficiencies andlead data-driven continuous improvement initiatives with measurable outcomes.

  • Define, monitor, and leverage quality and process performance metrics to drive sustained improvement and organizational learning.

  • Institutionalize improvements through procedures, governance, and training, including development and delivery of targeted training programs.

  • Other duties as assigned.

Education and Experience:

  • Bachelor's degree in engineering, Life Sciences, or related field (master's preferred)

  • 8+ years of experience in the medical device industry, withstrongknowledge of design controls and quality systems.

  • Proventrack recordin leading cross-functional continuous improvement projects.

  • Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.).

  • Experience implementing SDLC best practices in regulated environments.

  • Lean Six Sigma certification (Green Belt or higher) preferred.

  • Excellent communication, leadership, programmanagementand stakeholder management skills.

Skills/Competencies:

  • Effective verbal and written communication skills.

  • Experience collaborating and communicatingwith individuals at multiple levels in an organization.

  • Ability toprioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.

  • Strong analytical and problem-solving skills.

  • Able to work effectively in a high-stress, high-energyenvironment.

  • Ability toinfluencepeople and projects in a fast-moving environment.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $117,700.00 - $176,500.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: Medical, dental, and vision insurance 401(k) with company match Paid time off (PTO) And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)


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About Insulet

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

501 - 1,000 Employees

Headquarters location

Billerica, MA, US

Year founded

2000