QA Engineer

• Perform quality assurance reviews of peer review reports, correspondences, addendums, and supplemental reviews
• Ensure clear, concise, evidence-based rationales support recommendations and determinations
• Verify client instructions, specifications, and questions have been addressed
• Confirm clinical citations and references are current and from reputable medical journals or publications
• Ensure report content, format, and professional appearance meet company standards
• Verify appropriate board specialty review and accurate documentation
• Confirm peer reviewer attestation and absence of conflicts of interest
• Ensure provider credentials and signature are included in final reports
• Identify report inconsistencies and contact peer reviewers for clarification or correction
• Assist with customer complaints and quality assurance issues
• Ensure compliance with federal ERISA and state mandates
• Provide management with insight into consultant quality, availability, and compliance
• Promote effective and efficient use of company resources
• Participate in required educational and training activities
• Perform other assigned duties

Clinical Quality Assurance Coordinator

• Perform quality assurance reviews of peer review reports, correspondence, addendums and supplemental reviews
• Ensure clear, concise, evidence-based rationales support recommendations and determinations
• Verify client instructions, specifications and questions are addressed
• Confirm clinical citations and references are current and from reputable medical journals or publications
• Ensure report content, format and professional appearance meet company standards
• Verify appropriate board specialty review and accurate documentation
• Verify peer reviewer attestation and absence of conflicts of interest
• Ensure provider credentials and signatures are included in final reports
• Identify report inconsistencies and contact peer reviewers for clarification or corrections
• Assist with customer complaints and quality assurance issues
• Ensure compliance with federal ERISA and state mandates
• Provide management insight on consultant quality, availability and compliance
• Promote effective and efficient use of company resources
• Participate in required educational and training activities
• Perform other duties as assigned

• Serve as a key member of the program execution team
• Ensure successful program performance through conforming products and services
• Review and approve design artifacts and change requests for technical impact and quality
• Review and approve subcontract statements of work
• Assess technical risk of non-conformances
• Support and oversee failure investigations and nonconformance reviews
• Collaborate with cross-functional partners and customers to meet requirements
• Drive compliance with the Raytheon Quality Management System and continuous improvement
• Initiate root cause analysis and facilitate corrective actions
• Implement closed-loop process controls to improve product and process predictability and capability
• Implement Advanced Product Quality Planning in accordance with AS9145, as applicable
• Partner with the Program Quality Lead across the full product life cycle, including development, production, integration, testing, and sustainment

Senior Program Quality Engineer

• Support quality engineering activities for early-stage product development and pilot manufacturing operations
• Lead quality engineering activities for prototype, pilot, clinical, and development manufacturing builds
• Develop and maintain inspection plans, control plans, procedures, work instructions, and quality standards
• Define and implement inspection and test methodologies for product development, pilot manufacturing, and release activities
• Ensure compliance with design controls, traceability requirements, quality systems, and product documentation
• Support Design History File (DHF), Device History Record (DHR), lot release, and clinical build readiness activities
• Analyze quality and manufacturing data to identify trends, mitigate risks, and drive continuous improvement
• Lead investigations of nonconforming materials and products, perform root cause analysis, and implement CAPA
• Facilitate risk management activities, including DFMEA, PFMEA, and process control strategies
• Support qualification and validation of manufacturing equipment, inspection systems, test methods, and production processes (IQ/OQ/PQ)
• Partner with R&D and Manufacturing Engineering to improve manufacturability, inspectability, reliability, and process capability
• Support manufacturing transfer and commercialization through production quality controls and readiness assessments
• Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP requirements, and applicable regulatory standards
• Recommend inspection methods, sampling plans, acceptance criteria, and quality controls
• Evaluate nonconforming materials and products and provide disposition recommendations and corrective actions
• Identify, assess, and escalate product, process, and quality risks
• Provide quality engineering expertise during design reviews, risk assessments, validation activities, and manufacturing readiness reviews

Quality Engineer – NPI Programs

• Execute risk-based compliance testing engagements, including walkthroughs, sample selection, and detailed testing procedures
• Evaluate the design and operating effectiveness of key controls through hands-on testing
• Document testing activities, evidence, and conclusions in the company GRC platform
• Test adherence to internal policies, procedures, and applicable regulatory requirements
• Analyze testing results to identify control deficiencies, exceptions, and emerging risks
• Document findings and draft testing reports summarizing procedures performed, results, and issues identified
• Work with Audit Services, Risk, and Business Unit Compliance teams under guidance to support testing execution
• Support the US Segment as part of the Global Compliance Testing Team

Senior Tester, Global Compliance Testing

• Perform quality assurance reviews of peer review reports, correspondence, addendums, and supplemental reviews
• Ensure clear, concise, evidence-based rationales support recommendations and determinations
• Verify client instructions, specifications, questions, citations, and references are addressed and current
• Ensure reports meet company standards for content, format, and professional appearance
• Verify appropriate board specialty review and accurate documentation
• Verify peer reviewer attestation and absence of conflicts of interest
• Ensure provider credentials and signatures are included in final reports
• Identify report inconsistencies and contact peer reviewers for clarification or correction
• Assist with customer complaints and quality assurance issues
• Ensure compliance with federal ERISA and state mandates
• Provide management insight on consultant quality, availability, and compliance
• Promote efficient use of company resources
• Participate in required educational and training activities
• Perform other assigned duties

• Perform quality assurance reviews of peer review reports, correspondence, addendums, and supplemental reviews
• Ensure clear, concise, evidence-based rationales support recommendations and determinations
• Verify client instructions, specifications, questions, clinical citations, and current reputable references are addressed
• Ensure report content, format, appearance, and compliance with company standards
• Verify appropriate board specialty review and accurate documentation
• Verify peer reviewer attestation and absence of conflicts of interest
• Ensure provider credentials and signature are included in final reports
• Identify inconsistencies and contact peer reviewers for clarification, modification, or correction
• Assist with customer complaints and quality assurance issues
• Ensure compliance with federal ERISA and state mandates
• Provide management insight on consultant quality, availability, and compliance
• Promote effective and efficient use of company resources
• Participate in required educational and training activities
• Perform other duties as assigned

• Perform quality assurance review of peer review reports, correspondences, addendums, and supplemental reviews
• Ensure clear, concise, evidence-based rationales support recommendations and determinations
• Ensure client instructions and specifications are followed and all questions are addressed
• Verify clinical citations and references are current and obtained from reputable medical journals or publications
• Ensure report content, format, and professional appearance comply with company standards
• Confirm the appropriate board specialty reviewed each case in compliance with client specifications and state mandates
• Verify peer reviewer attestations and absence of reviewer conflicts of interest
• Ensure provider credentials and signatures are included in final reports
• Identify report inconsistencies and contact peer reviewers for clarification, modification, or correction
• Assist with customer complaints and quality assurance issues
• Ensure compliance with federal ERISA and state mandates
• Provide management insight on consultant quality, availability, and compliance
• Promote efficient utilization of company resources
• Participate in educational and training activities
• Perform other duties as assigned

• Maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies
• Work cross-functionally with quality assurance operations, quality control, manufacturing, validation, MS&T, and external vendors
• Gather, analyze, interpret, and report manufacturing and testing data for trending programs
• Address adverse trends and gaps through continuous improvement
• Track, manage, and complete cross-functional quality records including deviations, lab investigations, change controls, complaints, and CAPA
• Maintain quality metrics and KPIs for quality record trending
• Execute quarterly and annual quality record trending and escalate risks to the Quality Review Board
• Provide QA oversight for risk assessments and ensure regulatory-compliant quality risk management
• Support regulatory inspections, submissions, and internal/external audits
• Manage observation responses from inspections, submissions, and audits
• Own and manage the Product Recall process and execute the Annual Mock Recall
• Escalate quality defects to health authorities as applicable
• Serve as SME for Product Complaint Management and track commercial product complaints
• Participate in Joint Signal Detection meetings and generate complaint/change-control metrics
• Author, review, and approve GMP controlled documents, including quality manuals and compliance policies/procedures

Senior Manager, QA Compliance

• Maintain, update, and audit the company’s Quality Management System documentation, including SOPs, work instructions, and quality manuals
• Establish KPIs, collect performance data, and perform statistical analysis to monitor product and process health
• Identify trends, defects, and areas for improvement
• Partner with suppliers to define quality expectations and conduct supplier audits
• Implement Corrective and Preventive Actions (CAPA) with suppliers to improve inbound material and process quality
• Manage equipment calibration and maintenance schedules, execution, and documentation
• Lead investigations into product deviations, customer complaints, and internal non-conformances
• Use root-cause analysis methodologies such as 5 Whys and Fishbone to implement permanent solutions
• Train internal teams on quality protocols, compliance standards, and document control best practices

QA Engineer jobs in Massachusetts

Clinical Quality Assurance Coordinator

Clinical Quality Assurance Coordinator

Senior Program Quality Engineer

Quality Engineer – NPI Programs

Senior Tester, Global Compliance Testing

Clinical Quality Assurance Coordinator

Clinical Quality Assurance Coordinator

Clinical Quality Assurance Coordinator

Senior Manager, QA Compliance

Quality Assurance Specialist