QA Engineer

• Serve as the Product Quality Engineering lead for assigned product families throughout the product lifecycle.
• Monitor and analyze quality performance metrics, manufacturing yield data, complaint trends, service data, and field reliability indicators.
• Establish and maintain product quality dashboards and KPI reporting.
• Drive continuous improvement initiatives to improve product quality, reliability, manufacturability, and customer satisfaction.
• Act as the primary quality representative for cross-functional product teams.
• Lead investigations of product failures, nonconformances, customer complaints, and field-returned devices.
• Perform data-driven root cause analyses using quality tools including: 5 Whys Pareto Analysis Fishbone Analysis Statistical Analysis Fault Tree Analysis Failure Mode and Effects Analysis (FMEA).
• Identify systemic quality issues and implement sustainable corrective actions.
• Present investigation findings and recommendations to management and cross-functional teams.
• Lead CAPA activities from initiation through effectiveness verification and closure.
• Ensure timely investigation, documentation, and resolution of quality issues.
• Drive preventive actions that reduce recurrence and improve product robustness.
• Support management review activities through quality trend analysis and risk reporting.
• Serve as the primary quality partner for manufacturing operations and sustaining engineering teams.
• Support manufacturing process improvements to reduce defects, improve yields, and enhance product reliability.
• Evaluate production processes, inspection methods, and test strategies.
• Support process validations, equipment qualifications, software validations, and verification activities.
• Develop, review and approve manufacturing quality documentation, procedures, and work instructions.
• Represent Quality Engineering in design reviews, Engineering Change Orders (ECOs), and product change activities.
• Review and approve quality-related deliverables associated with product modifications.
• Support new product introduction (NPI), design transfer, and commercialization activities.
• Ensure quality and regulatory requirements are incorporated into product and process changes.
• Collaborate with Engineering teams to evaluate product risk and quality impact of design changes.
• Lead complaint evaluations, field investigations, and post-market surveillance activities.
• Analyze service data, complaint trends, and field performance information to identify emerging quality issues.
• Participate in Medical Device Reporting (MDR) assessments and regulatory reporting activities as required.
• Lead failure analysis activities for returned products and components.
• Recommend and implement improvements based on field performance data.

Senior Product Quality Engineer

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities.
• Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements.
• Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Senior Clinical Quality Assurance Associate

• Define and implement quality assurance strategies and test plans.
• Design, develop, and maintain automated and manual test suites for functional, regression, performance, and security testing.
• Oversee the automation of regression and sanity test cases, ensuring coverage and reliability.
• Enable automated data setup for recurring test scenarios to streamline test execution.
• Participate in defect triage meetings and drive root cause analysis for critical issues.
• Work closely with developers and product managers to understand requirements and ensure test coverage.

Senior Quality Engineer

• Play a critical role in supporting quality assurance and compliance efforts across the Primrose system
• Serve as an operational partner to the Director of Quality Assurance & Compliance
• Monitor, track, document, and resolve issues impacting health, safety, licensing, and brand standards
• Ensure concerns are addressed promptly and compliance-related processes are executed consistently and effectively
• Monitor incoming concerns, online reviews, and operational requests, ensuring timely review, prioritization, and appropriate escalation
• Partner with internal teams and field support to coordinate responses, follow-up actions, and resolution of concerns
• Manage cases through investigation, documentation, follow-up, and resolution while maintaining accurate records of actions and outcomes
• Communicate case updates and key information to stakeholders and elevate emerging trends or recurring issues as appropriate
• Support the Issues Management process through intake, fact gathering, documentation, and coordination of compliance-related matters
• Coordinate escalation of significant issues to the Issue Response Team, ensuring information is complete, accurate, and appropriately documented
• Monitor open issues, track status updates, and follow up with stakeholders to support timely resolution and accountability
• Assist with the development and distribution of compliance-related communications and notifications in partnership with internal stakeholders
• Maintain organized, audit-ready records and documentation related to compliance, issue management, and quality assurance activities
• Utilize company systems to enter, update, and manage compliance-related data, ensuring accuracy, consistency, and completeness
• Generate routine and ad hoc reports that provide visibility into trends, risks, issue status, and resolution timelines
• Support the continuous improvement of tools, templates, workflows, resources, and training materials that strengthen quality assurance, safety, and brand standards
• Collaborate with cross-functional teams to support issue resolution, process improvement, and system-wide quality initiatives

Quality Assurance Specialist

• Define the overall test strategy across web, desktop (Windows/macOS), and mobile, spanning manual and automated coverage
• Set standards for test design, edge-case and scale coverage, and defect triage across the engineering org
• Own test planning for major releases, prioritizing real-world usage scenarios and at-scale robustness
• Grow the QA function from its current manual-testing strength into a more automation-forward practice
• Introduce and scale automated testing (e.g., Selenium) and scripting (Python/Shell) where it adds the most leverage
• Evaluate and roll out bug tracking and test management tooling (e.g., Jira, TestRail, Zephyr) to fit team scale
• Leverage AI tools like Claude/ChatGPT to improve test coverage and automation
• Hire, mentor, and manage a QA team of manual and, over time, automation-focused engineers
• Establish clear defect management, escalation, and communication processes within an Agile/Scrum workflow
• Champion a quality-first culture across the product organization, not just within QA
• Work with Engineering to root-cause and prevent recurring issues in core file management functionality
• Own the go/no-go quality gate for production releases
• Build QA familiarity with encryption, privacy, and security testing concepts specific to our product
• Ensure test practices and evidence support CMMC, NIST 800-171, and FedRAMP requirements alongside Compliance

Director of Software Quality Assurance

• Lead ongoing implementation and continuous improvement of the Software Quality Management System (QMS)
• Serve as the Quality Lead for the cybersecurity process
• Guide software development teams in creation and maintenance of Design and Development Files (DDFs)
• Support ISO 14971 risk management, IEC 62366 usability engineering, and FDA cybersecurity guidance integration into SDLC
• Support post-market cybersecurity surveillance activities
• Provide CAPA, complaints, audit, and QMS support related to software and cybersecurity incidents

Senior Quality Engineer, Cybersecurity

• Perform the analysis of business requirements for accuracy, completeness, redundancy, ambiguity, and testability for multiple strategic software projects.
• Define the scope, approach, risks, and assumptions for testing.
• Design, build, and prioritize test cases.
• Execute manual and automated testing.
• Report and communicate test status and metrics to project stakeholders.
• Lead and/or participates in peer reviews of project deliverables.
• Work with stakeholders and development to define and develop testing requirements to validate software solutions were built to specifications.
• Plan, develop, execute, and maintain test cases, both manual and automated.
• Document and report defects within established process and tracking system.
• Create automated tests using JMeter for testing REST APIs and other test automation tools such as UFT or Tosca for UI tests.
• Integrate automated tests with CI/CD pipelines for continuous monitoring and alerting on failures.

• Provide strategic leadership and oversight for GCP quality assurance activities supporting clinical development programs.
• Lead the development, planning, and execution of GCP audits, including audits of clinical sites, CROs, vendors, and internal processes.
• Own and drive regulatory inspection readiness, including preparation for FDA and other health authority inspections, inspection conduct, and response to findings.
• Collaborate with Clinical Development and Clinical Operations teams to ensure studies are conducted in compliance with applicable GCP, regulatory requirements, and company SOPs.
• Provide expert guidance in the identification, investigation, and resolution of quality events, including deviations, CAPAs, and audit findings.
• Oversee and maintain the GCP quality systems, including processes for audit tracking, issue management, and quality metrics.
• Contribute to the development, implementation, and continuous improvement of quality systems, SOPs, and policies to support GCP compliance.
• Support cross-functional teams in the preparation and review of clinical documents and regulatory submissions from a quality perspective.
• Manage relationships with external vendors and partners to ensure quality expectations are clearly defined and met.
• Provide mentorship and guidance to junior QA staff and serve as a key quality resource across the organization.

Associate Director, Quality Assurance, GCP

• Design and implement comprehensive test strategies for Guidewire applications to ensure product quality and reliability.
• Collaborate with development teams to understand product requirements and translate them into effective test cases.
• Execute manual and automated tests using tools like Selenium and Cucumber to validate software functionality.
• Identify, document, and track defects using appropriate tools ensuring timely resolution and retesting.
• Develop and maintain test scripts for SOAP, WSDL, and REST Web Services to ensure seamless integration and performance.
• Provide detailed test reports and metrics to stakeholders highlighting key findings and areas for improvement.
• Conduct regression testing to ensure new features do not adversely affect existing functionality.
• Utilize Core Java skills to enhance test automation frameworks and improve testing efficiency.

QA Automation Testing

• Responsible for supplier quality engineering (SQE) deliverables to support Plastics category sourcing strategies and continuity of production.
• Develop and monitor key performance indicators (KPIs) and other metrics.
• Lead SQE efforts in sustaining projects to accomplish primary objectives, including cost reduction, capacity increase, dual sourcing, and risk mitigation.
• Engage partnerships with suppliers and supply chain management (SCM) to drive superior supplier performance and accountability.
• Lead root cause analysis of supplier-related non-conforming product issues to address and resolve quality concerns.

Senior Supplier Quality Engineer

• Performs quality assurance review of peer review reports, correspondences, addendums or supplemental reviews.
• Ensures clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations.
• Ensures that all client instructions and specifications have been followed and that all questions have been addressed.
• Ensures each review is supported by clinical citations and references when applicable and verifies that all references cited are current and obtained from reputable medical journals and/or publications.
• Ensures the content, format, and professional appearance of the reports are of the highest quality and in compliance with company standards.
• Ensure that the appropriate board specialty has reviewed the case in compliance with client specifications and/or state mandates and is documented accurately on the case report.
• Verifies that the peer reviewer has attested to only the fact(s) and that no evidence of reviewer conflict of interest exists.
• Ensures the provider credentials and signature are adhered to the final report.
• Identifies any inconsistencies within the report and contacts the Peer Reviewer to obtain clarification, modification or correction as needed.
• Assists in resolution of customer complaints and quality assurance issues as needed.
• Ensures all federal ERISA and/or state mandates are adhered to at all times.
• Provides insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications.
• Promote effective and efficient utilization of company resources.
• Participate in various educational and or training activities as required.
• Perform other duties as assigned.

Clinical Quality Assurance Coordinator

• Oversee the daily workflow of the Quality Assurance Department and provide leadership and direction to ensure operations run as efficiently and effectively as possible.
• Coordinate and direct the QA department’s daily workflow to ensure all product lines are completed with the highest level of quality in the most effective and efficient manner possible.
• Prioritize and manage the daily workload and ensure the appropriate and equitable distribution of work is maintained in order to achieve goals.
• Monitor work product to ensure clear, concise, evidence-based rationales have been provided in support of all recommendations or determinations and that specific indicators and criteria in accordance with company policy and procedures have been achieved.
• Ensure department compliance of all federal ERISA and state mandates is adhered to at all times.
• Promote effective and efficient utilization of all clinical resources and makes necessary recommendations for improvements to management as needed.
• Ensure all client relationships are maintained and all client specific requirements are met.
• Assist promptly in resolution of any physician and/or customer complaints or quality assurance issues.
• Delegate work as needed and provide backup to all departmental positions as required.
• Provide insight and direction to management on consultant quality, availability and compliance with all company policies and procedures.
• Participate in the development and implementation of policies and procedures in order to promote and achieve the most efficient operation possible.
• Participate in various educational and or training activities as required.
• Perform other duties as assigned.

Clinical Quality Assurance Coordinator – Supervisor

• Provide quality leadership on new product project teams responsible for the development of medical device software systems.
• Be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
• Partner with R&D to refine requirements, and to ensure compliant architecture/design documents.
• Own the development of risk documents and facilitate software risk assessment sessions.

Staff Quality Engineer – Product Quality

• Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
• Provide leadership, guidance and expertise on the software development process, procedures and practices.
• Communicate business related issues or opportunities to next management level.
• Follow all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Tracking and triaging findings from third-party assessments, ensuring timely follow-up and remediation tracking.
• Collaborating with development, platform, and product teams to communicate findings, track remediation efforts, and improve overall security posture.
• Facilitating post-assessment reviews and lessons learned sessions with development teams to identify recurring security issues and promote secure development practices.
• Maintaining program documentation, test records, and reporting artifacts.
• Conducting penetration testing of web applications, APIs, cloud environments, and internal systems, escalating complex testing scenarios as needed.
• Performing peer review of penetration testing deliverables, including test plans, findings, and final reports.
• Participating in scoping exercises and contributing to the selection of appropriate testing methodologies.
• Supporting security assessments of GenAI-powered applications and features, including LLM integrations, RAG pipelines, and AI agents.
• Assisting in testing for AI-specific vulnerabilities such as prompt injection, jailbreaking, insecure output handling, model data leakage, and training data poisoning.
• Contributing to the development of internal GenAI security testing checklists and methodologies, aligned with frameworks such as OWASP Top 10 for LLMs.

Security Assurance Penetration Tester

• Lead, coach, and develop a team of Quality Consultants
• Foster a high-performance, consultative and innovation-focused culture
• Deliver and enhance reporting to leadership, identifying actionable trends and insights across QA data
• Collaborate with Business Partners, Training, Risk, Audit, and Technology partners to address quality themes
• Maintain strong oversight of QA processes, controls, and governance
• Champion a continuous improvement mindset, using data and technology to drive efficiency

Senior Manager, Quality Assurance

• Apply deep expertise in specific product areas to ensure that all features meet documented acceptance criteria and client quality expectations
• Design and execute comprehensive test plans for complex features, including thorough web service and API-level testing
• Identify gaps in test coverage and drive improvements proactively, collaborating with engineers and product owners to incorporate quality thinking early in the development cycle
• Debug complex, multi-layered issues spanning the application, database, and integration layers — digging into root causes rather than stopping at the surface
• Provide feedback on product performance and user experience
• Serve as a quality mentor and go-to resource for Engineers on your squad and across the organization
• Contribute to the review of product documentation and release notes for new versions
• Leverage AI tools (e.g., Claude, Glean) to accelerate test planning, documentation, and root cause analysis
• Contribute to the growth and development of our core values: We Before Me, Positive Energy, Knowledge Explorer, and Own It.

Senior QA Engineer

• Implementing quality standards in software development and testing processes
• Identifying and resolving software defects to optimize performance and enhance user experience
• Conducting functional and compatibility testing to validate software reliability
• Designing and managing quality assurance processes to improve software quality
• Collaborating with teams to develop and execute test cases and protocols
• Engaging in post go-live support to address and resolve any emerging issues

Senior AI Quality Assurance Associate

• Responsible for ensuring case reports are of the highest quality and integrity.
• Handle quality assurance questions and provide support to the Quality Assurance Department.
• Perform quality assurance review of peer review reports, correspondences, addendums or supplemental reviews.
• Ensure clear, concise, evidence-based rationales have been provided in support of all recommendations and/or determinations.
• Ensure that all client instructions and specifications have been followed and that all questions have been addressed.
• Verify that the peer reviewer has attested to only the facts and that no evidence of reviewer conflict of interest exists.
• Assist in resolution of client complaints and quality assurance issues as needed.

• Serve as the QA lead for assigned GMP-related activities including quality oversight of CDMOs, tech transfer, scale-up, manufacturing (cell bank, DS, DP, FDP), and disposition of clinical materials
• Quality reviewer and approver for quality records such as change controls, CAPAs, deviations, temperature excursions, product complaints, expiry/retest, stability protocols/reports, master batch records, method qualifications, etc.
• Collaborate with CMC, Supply Chain, Analytical Development and Program Management to ensure on-time delivery of products and compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations
• Supports archival of documents/records, quality metrics and develop/maintain QA related tracking logs
• Work directly with operating entities (internal and CMOs) to ensure that product(s) meet all required quality standards and specifications
• Supports management of Quality Agreements, including project coordination, cross-functional review, and approval workflows
• Represent the Quality function in product development (CMC) teams to provide proactive quality guidance and decisions
• Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide the highest level of quality services to Jade
• Lead quality risk management activities to proactively identify, assess, and mitigate GMP-related risks across manufacturing and supply operations
• Facilitate resolution of quality issues with internal and external parties in a timely manner
• Coordinate communications with CMOs and internal technical product teams on quality issues
• Review CMC sections of regulatory filings, as needed
• Collaborate cross-functionally with CMC, Regulatory, Clinical Supply Chain, and Program Leadership teams to ensure quality is embedded across development and manufacturing activities
• Participate in and support regulatory authority inspections and internal audits
• Supports development/maintenance of Quality SOPs
• Contribute to the development and maintenance of a positive team-focused company culture
• Other duties, as assigned

QA Engineer jobs in Massachusetts

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Senior Product Quality Engineer

Senior Clinical Quality Assurance Associate

Senior Quality Engineer

Quality Assurance Specialist

Director of Software Quality Assurance

Senior Quality Engineer, Cybersecurity

Senior Quality Engineer

Associate Director, Quality Assurance, GCP

QA Automation Testing

Senior Supplier Quality Engineer

Clinical Quality Assurance Coordinator

Clinical Quality Assurance Coordinator – Supervisor

Staff Quality Engineer – Product Quality

Staff Quality Engineer – Product Quality

Security Assurance Penetration Tester

Senior Manager, Quality Assurance

Senior QA Engineer

Senior AI Quality Assurance Associate

Clinical Quality Assurance Coordinator

Director, GMP Quality Assurance