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Senior Software Quality Assurance Engineer

Katalyst Healthcares and Lifesciences

Andover, Massachusetts • Today

Full-time

Software Quality Assurance Engineer

Axcelis Technologies

Beverly, Massachusetts • Today

Full-time

USD 78,789.48 - 118,184.22 per year

Software Quality Assurance Engineer III

Axcelis Technologies

Beverly, Massachusetts • Today

Full-time

USD 99,120.00 - 148,680.00 per year

Software Quality Assurance Engineer II/III

Textron, Inc.

Wilmington, Massachusetts • Today

Full-time

USD 92,600.00 - 139,600.00 per year

Software Quality Assurance (SQA) Engineer I

Axcelis Technologies

Beverly, Massachusetts • Today

Full-time

USD 99,120.00 - 148,680.00 per year

Software Quality Assurance Engineer, AVP

State Street Corporation

Burlington, Massachusetts • Today

Full-time

USD 80,000.00 - 140,000.00 per year

AI QA Engineer, AVP

State Street Corporation

Burlington, Massachusetts • Today

Full-time

USD 80,000.00 - 140,000.00 per year

Senior Quality Automation Specialist, AVP

State Street Corporation

Quincy, Massachusetts • 2d ago

Full-time

USD 90,000.00 - 157,500.00 per year

Software & Model Quality Assurance Engineer

Draper

Cambridge, Massachusetts • Today

Full-time

USD 95,000.00 per year

Principal Software Quality Engineer

Draper

Cambridge, Massachusetts • Today

Full-time

USD 95,000.00 per year

Software Quality Engineer, Officer

State Street Corporation

Burlington, Massachusetts • Today

Full-time

USD 65,000.00 - 113,750.00 per year

Software Quality Assurance Analysts and Testers

4 Consulting Inc

Remote • Today

Easy Apply

Full-time, Third Party

Depends on Experience

Software Quality Assurance Analysts and Testers

4 Consulting Inc

Remote • Today

Easy Apply

Full-time, Third Party

Depends on Experience

Software Quality Assurance Analysts and Testers

4 Consulting Inc

Remote • Today

Easy Apply

Full-time, Third Party

Depends on Experience

Software QA Automation Engineer

Cogent Data Solutions Llc

Remote • Today

Easy Apply

Contract

Depends on Experience

Software QA Engineer

Yoh - A Day & Zimmerman Company

Remote or Mountain View, California • Today

Easy Apply

Full-time

USD35 - USD45 per hour, Benefits: $35-45/hr. Depends on work experience

Engineer I, Software Quality

Fujifilm

Remote • Today

Full-time

Senior Staff Software Advance Quality Engineer

Stryker

Remote or Detroit, Michigan • Today

Full-time

USD 102,600.00 - 171,000.00 per year

Software QA Engineer

Allied Consultants, Inc.

Remote • Today

Easy Apply

Third Party, Contract

Depends on Experience

Software QA Engineer

Allied Consultants, Inc.

Remote • Today

Easy Apply

Third Party, Contract

Depends on Experience

Software QA Engineer

Cogent Data Solutions Llc

Remote • Today

Easy Apply

Contract

Depends on Experience

Software Design Quality Engineer

Philips North America

Bedford, Massachusetts • Today

Full-time

USD 102,480.00 - 163,968.00 per year

Job Details

Skills

Software Quality Assurance
QA Management
Change Management
DMR
Verification And Validation
Regulatory Compliance
Design Software
Root Cause Analysis
Continuous Improvement
IDE
Medical Devices
Design Controls
ISO 13485
ISO 9000
Quality Assurance
Software Development Methodology
Risk Management
FMEA
Product Development
Auditing
Analytical Skill
Documentation
Communication
Quality Management
Product Lifecycle Management
Plant Lifecycle Management
Corrective And Preventive Action
Management

Software Quality Assurance
QA Management
Change Management
DMR
Verification And Validation
Regulatory Compliance
Design Software
Root Cause Analysis
Continuous Improvement
IDE
Medical Devices
Design Controls
ISO 13485
ISO 9000
Quality Assurance
Software Development Methodology
Risk Management
FMEA
Product Development
Auditing
Analytical Skill
Documentation
Communication
Quality Management
Product Lifecycle Management
Plant Lifecycle Management
Corrective And Preventive Action
Management

Summary

Job Description

As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end 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 post-market activities.

Key Responsibilities
In this role you will play a key role in:

Serving as the quality lead on product development teams, ensuring compliance with design controls 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
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
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)

Required Skills

10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
Experience supporting software quality within the SDLC and understanding of software risk management principles
Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: ba4194cfca537bef0544255906166cea
Posted 30+ days ago

Fitment

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Similar Jobs

Senior Design Quality Engineer

Hybrid in Andover, Massachusetts

•

4d ago

Job Description - Role name: Senior Design Quality Engineer Work Location: Andover, MA (Hybrid 3 days onsite) Duration: 3 Months (C2H) Qualifications: o Bachelor s degree in Engineering (Biomedical, Software, Systems) or a related technical discipline o Advanced degree (Master s) in Engineering, Quality, or Regulatory Affairs preferred o Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus Job Description As a Senior Design Quality Engineer (DQE) for our medical d

Easy Apply

Contract

$40 - $60

Product Design Quality Engineer

Cambridge, Massachusetts

•

Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Software Design Assurance Eng

Bedford, Massachusetts

•

Today

Job Title Software Design Assurance Eng Job Description The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle. Your role: Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.Lead in the effective applicati

Full-time

USD 102,480.00 - 163,968.00 per year

Engineer IV/Complaint Analysts

Lexington, Massachusetts

•

6d ago

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Join Takeda as an Engineer IV, Complaint Analysts. As part of the Engineer IV, Complaint Analysts, you're adept at solving a range of

Full-time

USD 103,500.00 - 162,690.00 per year

Job Details

Skills

Software Quality Assurance
QA Management
Change Management
DMR
Verification And Validation
Regulatory Compliance
Design Software
Root Cause Analysis
Continuous Improvement
IDE
Medical Devices
Design Controls
ISO 13485
ISO 9000
Quality Assurance
Software Development Methodology
Risk Management
FMEA
Product Development
Auditing
Analytical Skill
Documentation
Communication
Quality Management
Product Lifecycle Management
Plant Lifecycle Management
Corrective And Preventive Action
Management

Software Quality Assurance
QA Management
Change Management
DMR
Verification And Validation
Regulatory Compliance
Design Software
Root Cause Analysis
Continuous Improvement
IDE
Medical Devices
Design Controls
ISO 13485
ISO 9000
Quality Assurance
Software Development Methodology
Risk Management
FMEA
Product Development
Auditing
Analytical Skill
Documentation
Communication
Quality Management
Product Lifecycle Management
Plant Lifecycle Management
Corrective And Preventive Action
Management

Summary

Job Description

As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end 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 post-market activities.

Key Responsibilities
In this role you will play a key role in:

Serving as the quality lead on product development teams, ensuring compliance with design controls 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
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
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)

Required Skills

10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
Strong hands-on experience with design controls, DHF management, and traceability in regulated environments
Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
Experience supporting software quality within the SDLC and understanding of software risk management principles
Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

Dice Id: 91116760
Position Id: ba4194cfca537bef0544255906166cea
Posted 30+ days ago

Fitment

Dice Job Match Score™

🔗 Matching skills to job...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Senior Design Quality Engineer

Hybrid in Andover, Massachusetts

•

4d ago

Easy Apply

Contract

$40 - $60

Product Design Quality Engineer

Cambridge, Massachusetts

•

Today

Full-time

Software Design Assurance Eng

Bedford, Massachusetts

•

Today

Full-time

USD 102,480.00 - 163,968.00 per year

Engineer IV/Complaint Analysts

Lexington, Massachusetts

•

6d ago

Full-time

USD 103,500.00 - 162,690.00 per year