Quality Assurance Engineer Jobs in Boston, MA
Quality Assurance Engineer jobs in Boston are active across the Seaport District, Kendall Square, and the Longwood Medical Area, with strong demand in biotech, medtech, and enterprise software. Employers hiring right now include Amgen, Prenuvo, and CarGurus. Scan the live roles below and apply to whichever ones fit.
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We are seeking an experienced Quality Assurance Engineer Medical Devices to support quality engineering activities throughout the product development and manufacturing lifecycle. The ideal candidate will have strong experience in medical device quality, process verification and validation, Design/Process FMEA, Design Controls, risk management, and product testing.
Roles and Responsibilities
- Conduct and support Process Verification and Process Validation (PV/PPQ) activities in accordance with established procedures and regulatory requirements.
- Develop, review, and maintain Design FMEA (DFMEA) and Process FMEA (PFMEA) documentation.
- Support Design Control activities throughout the product development lifecycle.
- Perform product and process risk management and risk assessments.
- Support product testing, verification, and validation activities and ensure appropriate documentation is completed.
- Interpret engineering blueprints, drawings, GD&T, and technical specifications.
- Participate in New Product Development (NPD) activities and provide quality engineering support from development through production implementation.
- Support CAPA, nonconforming material, deviation, and corrective/preventive action processes.
- Investigate quality issues using structured root-cause analysis and problem-solving methodologies.
- Support compliance with applicable medical device quality and regulatory requirements.
- Collaborate with manufacturing and onsite teams to ensure successful implementation of validated processes and quality requirements.
- Work cross-functionally with Engineering, Manufacturing, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues.
- Participate in continuous improvement initiatives using Lean, Six Sigma, and other quality improvement methodologies.
- Provide quality input and technical support to senior leadership on quality initiatives and improvement programs.
- Manage multiple projects and priorities while meeting established timelines and quality objectives.
- Prepare, review, and maintain quality documentation, reports, and technical records.
- Bachelor's degree in engineering, Science, or another relevant technical discipline.
- 5+ years of experience in the medical device industry, preferably in Quality Engineering or Quality Assurance.
- Hands-on experience with Process Verification and Validation.
- Experience with risk management, product testing, and quality problem-solving.
We are seeking an experienced Quality Assurance Engineer Medical Devices to support quality engineering activities throughout the product development and manufacturing lifecycle. The ideal candidate will have strong experience in medical device quality, process verification and validation, Design/Process FMEA, Design Controls, risk management, and product testing.
Roles and Responsibilities
- Conduct and support Process Verification and Process Validation (PV/PPQ) activities in accordance with established procedures and regulatory requirements.
- Develop, review, and maintain Design FMEA (DFMEA) and Process FMEA (PFMEA) documentation.
- Support Design Control activities throughout the product development lifecycle.
- Perform product and process risk management and risk assessments.
- Support product testing, verification, and validation activities and ensure appropriate documentation is completed.
- Interpret engineering blueprints, drawings, GD&T, and technical specifications.
- Participate in New Product Development (NPD) activities and provide quality engineering support from development through production implementation.
- Support CAPA, nonconforming material, deviation, and corrective/preventive action processes.
- Investigate quality issues using structured root-cause analysis and problem-solving methodologies.
- Support compliance with applicable medical device quality and regulatory requirements.
- Collaborate with manufacturing and onsite teams to ensure successful implementation of validated processes and quality requirements.
- Work cross-functionally with Engineering, Manufacturing, R&D, Regulatory, Operations, and other stakeholders to resolve quality issues.
- Participate in continuous improvement initiatives using Lean, Six Sigma, and other quality improvement methodologies.
- Provide quality input and technical support to senior leadership on quality initiatives and improvement programs.
- Manage multiple projects and priorities while meeting established timelines and quality objectives.
- Prepare, review, and maintain quality documentation, reports, and technical records.
- Bachelor's degree in engineering, Science, or another relevant technical discipline.
- 5+ years of experience in the medical device industry, preferably in Quality Engineering or Quality Assurance.
- Hands-on experience with Process Verification and Validation.
- Experience with risk management, product testing, and quality problem-solving.
See All 111+ Quality Assurance Engineer Jobs in Boston
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Find JobsQuality Assurance Engineer Job Market in Boston
Who's Hiring
- Amgen11
- Prenuvo11
- CarGurus11
- Envestnet11
- Care Access11
Top Industries Hiring
- Technology & Software
Quality Assurance Engineer Jobs in Boston: Frequently Asked Questions
How do I get a quality assurance engineer job in Boston?
Focus your search on Boston's three dominant hiring clusters: life sciences and medtech firms concentrated in the Longwood Medical Area and along the Route 128 corridor, enterprise software companies in the Seaport District, and biotech employers anchored around Kendall Square in nearby Cambridge. Candidates who can demonstrate experience with FDA-regulated environments or automated testing frameworks stand out in this market, since both skills appear across all three sectors.
Which companies hire quality assurance engineers in Boston?
Companies currently hiring quality assurance engineers in Boston include Amgen, Prenuvo, and CarGurus, per current listings on Migrate Mate as of September 2026. Boston's employer mix skews heavily toward medical device makers, pharmaceutical companies, and software firms, so hiring tends to be consistent year-round rather than seasonal.
Are there remote quality assurance engineer jobs in Boston?
Yes, though it depends on the type of work: analytical and automation-focused roles are routinely remote, while positions involving physical product testing or lab equipment require on-site presence. About 71% of quality assurance engineer openings tied to Boston are remote or hybrid as of September 2026. Software and SaaS employers in the Seaport District offer the most remote flexibility locally.
How can I get a quality assurance engineer job in Boston with little or no experience?
The most realistic entry path in Boston is through junior QA analyst or software tester roles at mid-size software companies in the Seaport or at contract-to-hire staffing firms that place candidates with Boston's biotech sector. Northeastern University's co-op program and local bootcamp graduates regularly land these roles. Building a portfolio of automated test scripts and earning an ISTQB foundation certification gives entry-level candidates a concrete edge with Boston employers.
Which industries hire the most quality assurance engineers in Boston?
Boston quality assurance engineer roles concentrate in Technology & Software, based on current listings on Migrate Mate as of September 2026. Boston's dense cluster of FDA-regulated life sciences companies and venture-backed software firms drives unusually high and consistent demand for QA talent compared to most other U.S. cities.
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