QA 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

• Govern the Unified 'Definition of Ready' Framework
• Enforce non-negotiable experience quality gates
• Drive the Automation & Shift-Left Pipeline Strategy
• Establish Next-Gen Testing Guardrails
• Optimize Elastic Vendor Resourcing
• Govern Predictive Risk Management & Escape Audits
• Embed Structural Compliance & Audit Automation

Senior Director, Experience Assurance – UAT, Quality Innovation

• Develop and execute test plans, test cases, test scripts and test Summary to ensure thorough coverage of software functionalities, including functional, regression, integration, and performance testing.
• Collaborate with cross-functional teams, including developers, product managers, and business analysts, to understand requirements, identify test scenarios, and ensure alignment with business objectives.
• Utilize strong technical expertise in automation tools and technologies to design, develop, and maintain automated test suites for continuous integration and deployment pipelines.
• Proficient in performing manual testing of web-based and API-based applications with focus on complex scenarios and edge cases, to ensure comprehensive test coverage.
• Analyze and troubleshoot issues, defects, and discrepancies, documenting and tracking them to resolution using issue tracking systems.
• Develop and maintain SQL queries for data validation and verification.

Senior Quality Engineering Lead

• 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

• Perform quality assurance activities related to API manufacturing in a complex, clinical supply development
• Review and/or approve GMP documents
• Ensure all API manufactured in compliance with cGMP and regulatory filings
• Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product
• Make independent batch release or reject decisions
• Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
• Accountable for all assigned projects and communication of status to the Management Team
• Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels
• Establish, educate, and enforce standard operating procedures (SOPs) required under GMP
• Develop/update SOPs to ensure practices are accurately reflected
• Assist in SOP and quality-related system document approval
• Support metrics by summarizing findings during documentation reviews
• Collect, prepare and analyze data to support quality system metrics and planning
• Support compliance activities such as site readiness, audits, inspections, and CAPAs
• Support quality risk management activities as facilitator, project lead and/or quality subject matter expert
• Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency
• Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert
• Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables
• Exercise broad judgment in making quality decisions and solving complex problems
• Escalate issues as needed
• Provide meeting coordination, facilitation, scribing, and communication.

Senior Specialist, Quality Assurance

• Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.
• Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs through enhancing the audit report peer review process and the analysis and communications of meaningful audit outcomes.
• Monitors audit outcome trends and identification of pro-active collaboration opportunities with stakeholders to resolve and address compliance related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.
• Maintains and shares expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• Leverages data analytics tools to analyze relevant data sources.
• Evaluates and analyzes the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.
• Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.
• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
• Ensures the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.
• Independently leads and manages the domain-specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable (Health Authority) regulatory requirements.
• Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).

Manager, Clinical QA Program Lead

• Drive and deliver audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
• Foster the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs through enhancing the audit report peer review process and the analysis and communications of meaningful audit outcomes.
• Monitor audit outcome trends and identification of pro-active collaboration opportunities with stakeholders to resolve and address compliance related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.
• Maintain and share expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• Conduct GCP audits & support GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.

• Design and execute comprehensive test plans and test cases for new features and system enhancements.
• Lead regression testing efforts to ensure stability across releases.
• Collaborate with developers, product managers, and business analysts to clarify requirements and resolve design issues.
• Document and manage detailed defect reports, including reproduction steps and severity assessments.
• Participate in Agile ceremonies and contribute to sprint planning and retrospectives.
• Maintain and enhance automated UI and API test suites.
• Analyze test results and provide actionable feedback to development teams.
• Contribute to the development and documentation of QA processes and standards.
• Mentor junior QA testers and support their professional development.

Quality Assurance Tester II

• 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

• Provide global Source Quality Management support by leading supplier and purchasing controls, including supplier selection, qualification, monitoring, change management, and Approved Supplier List management.
• Partner with suppliers and cross-functional stakeholders to investigate, resolve, and prevent supplier-related quality issues, minimize business disruptions, and support robust materials, products, processes, and systems.
• Monitor supplier performance, analyze quality data and trends, communicate risks, and drive quality risk management, corrective actions, targeted improvements, and supplier relationship management activities.
• Lead supplier quality projects, component qualification changes, quality agreements, and process/product improvement initiatives using project management, Quality Engineering, and continuous improvement tools.
• Ensure compliance with applicable quality system, regulatory, environmental, health, safety, and company requirements while communicating business issues and opportunities to management.

Staff Source Quality Engineer

• Provide global Source Quality Management support by leading supplier and purchasing controls, including supplier selection, qualification, monitoring, change management, and Approved Supplier List management.
• Partner with suppliers and cross-functional stakeholders to investigate, resolve, and prevent supplier-related quality issues.
• Monitor supplier performance, analyze quality data and trends, communicate risks, and drive quality risk management, corrective actions, targeted improvements, and supplier relationship management activities.
• Lead supplier quality projects, component qualification changes, quality agreements, and process/product improvement initiatives using project management, Quality Engineering, and continuous improvement tools.
• Ensure compliance with applicable quality system, regulatory, environmental, health, safety, and company requirements while communicating business issues and opportunities to management.

• Design and Develop Data Testing Solutions
• Build, maintain, and optimize automated data testing frameworks and validation pipelines that support enterprise reporting, analytics, and business applications using SQL, Informatica, IICS, Snowflake, and Python.
• Data Validation and Quality Assurance
• Develop and execute data validation routines for extracts, transformations, and reporting datasets to ensure completeness, accuracy, consistency, and reliability of enterprise data assets.
• Test Automation and Reconciliation
• Design automated reconciliation processes between source and target systems, including row count validation, schema validation, transformation testing, and data profiling.
• Data Pipeline Quality Engineering
• Partner with data engineering teams to embed testing and quality controls into ETL/ELT pipelines and CI/CD deployment processes across Snowflake, Oracle, and AWS environments.
• AI-Enabled Test Development and Automation
• Leverage AI-assisted development tools and intelligent automation techniques to improve test coverage, accelerate validation processes, and enhance the efficiency of data quality engineering practices across enterprise data platforms.
• Test Environment Strategy and Management
• Support and contribute to enterprise test environment strategy, including environment planning, test data management, deployment coordination, integration testing support, and validation across development, QA, UAT, and production environments.
• Data Governance and Compliance
• Ensure compliance with enterprise data governance, security, and regulatory requirements by implementing data quality standards, monitoring controls, and audit-ready validation processes.
• Integration and Monitoring
• Work with structured and semi-structured data formats (XML, JSON) and cloud-native services to validate data ingestion, transformation, and integration processes across distributed platforms.
• Collaboration and Leadership
• Collaborate with data engineers, analysts, QA teams, and business stakeholders to define testing requirements, improve data quality processes, and support reporting solutions such as Power BI.
• Continuous Improvement
• Recommend and implement improvements to data quality frameworks, testing automation, monitoring solutions, governance processes, and DataOps practices.
• Mentor junior team members and promote best practices in data quality engineering and testing.

Data Quality Engineer

• Define quality strategies and own test planning from requirements through release, partnering closely with cross-functional teams
• Design and execute scalable functional, regression, and integration testing strategies
• Apply hands-on automation framework expertise across UI, API, and backend layers to support major product initiatives
• Test AI-driven functionality, including LLM agents, multi-agent workflows, and RAG pipelines
• Validate AI outputs for accuracy, relevance, consistency, and edge cases across non-deterministic systems
• Own evaluation frameworks (e.g., RAGAS), test datasets, and regression baselines for AI features
• Stay current with the evolving landscape of LLM evaluation, agent testing, and AI observability, and translate emerging techniques into practical testing approaches
• Lead QE team for your project by setting technical direction, defining quality strategy, and ensuring delivery confidence
• Contribute to QE standards and frameworks within your project scope, establishing practices that other engineers can adopt
• Integrate automated tests into CI/CD pipelines and partner with engineering leads to embed quality into the delivery process
• Leverage data, risk signals, and production insights to continuously improve test coverage and effectiveness

Staff Quality Assurance Engineer

• Independently architect, scale, and own the E2E test strategy for complex web applications.
• Build, maintain, and optimize robust automation frameworks utilizing Cypress and TypeScript/JavaScript to improve e2e coverage and automate production smoke testing.
• Automate and embed production smoke tests and regression suites directly into our CI/CD pipelines to ensure rapid, high-confidence deployments.
• Perform root-cause analysis on e2e failures, flaky tests, and pipeline bottlenecks by digging into Cypress and backend logs and interacting closely with software engineers.
• Lead high-impact testing initiatives and author clear, actionable technical documentation.

Lead Quality Engineer

• Responsible for monitoring and documenting Del Monte’s Quality and Food and Safety Programs.
• Implementation of, and adherence to, all Quality, Food Safety and Sanitation guidelines.
• Perform inbound inspections.
• Perform re-inspections in the warehouse.
• Perform quality checks on assigned orders.
• Monitor warehouse and vessel discharge temperatures and ethylene levels.
• Conduct quality control inspections on a regular basis and as required by the operations.
• Supervise quality control inspections at the facility.
• Special Projects as assigned.

Quality Assurance Technician

• Lead enterprise quality validation strategy for end-to-end business workflows, cross-platform integrations, and multi-segment technology initiatives.
• Establish standards and operating models for integration assurance, release certification, automation, resiliency testing, and production quality validation.
• Provide technical leadership for complex validation scenarios, including dependency mapping, risk-based test planning, automation strategy, test data needs, and environment readiness.
• Partner across engineering, architecture, product, DevOps, release management, operations, cybersecurity, and platform teams to manage quality risks, resolve defects, and improve release readiness.
• Advance automation-first and AI-enabled quality engineering practices to improve test planning, defect analysis, risk prediction, release confidence, and quality insights.
• Own enterprise release certification, including readiness criteria, quality gates, executive reporting, risk escalation, and go/no-go recommendations.
• Drive reliability, resiliency, synthetic monitoring, smoke testing, post-release validation, and production quality practices for critical workflows and integrations.
• Define quality metrics, dashboards, and governance routines to provide visibility into validation progress, dependency risk, defect trends, release readiness, and production outcomes.
• Build and develop a high-performing quality engineering team while fostering a culture of technical excellence, accountability, collaboration, and continuous improvement.

Director, Enterprise Quality Engineering

• Lead end-to-end RAQA program delivery, building cross-functional teams and securing resources
• Translate stakeholder and customer requirements into project scope and execution plans
• Own program budgets, forecasts, and financial tracking
• Drive stakeholder alignment through communication and adherence to project plans
• Proactively manage risk focusing on compliance and product quality
• Monitor program performance with defined KPIs and metrics
• Strengthen team effectiveness by coaching, mentoring, and influencing team members
• Coordinate and guide cross-functional contributors for successful program execution

Program Manager, RAQA

• Review and assess proposed product performance claims against industry, regulatory, and company requirements in an unbiased, professional manner.
• Validate claimed product features and benefits by analyzing technical substantiation such as clinical studies, technical data sheets, and testing reports.
• Guide vendors on required claim support and ensure final approved claims align with the level of substantiation provided.
• Partner with Legal to keep approved claims compliant with FTC requirements, truth-in-advertising standards, and expected customer experience.
• Provide technical guidance, training, and root-cause-driven CAPA support to resolve recurring claim issues and strengthen stakeholder knowledge.
• Track vendor and process performance to identify trends and drive corrective actions and QA process improvements that increase efficiency and speed to market.

QA Performance Claims Specialist

• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs
• Support Design Reviews, Technical Reviews, and Gate Reviews
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs
• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA)
• Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution
• Coordinate, review and approve development documentation created by external partners
• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer
• Maintains knowledge of and applies statistical analysis to support data-driven decision making
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
• Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
• Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
• Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Identify and implement opportunities for continuous improvement in the quality system
• Interact and coordinate activities with other departments, external vendors, and customers
• Perform other Quality Systems related duties as required

Senior Quality Engineer, Design Assurance

• Work independently within broad guidelines, policies and the operational plan to impact a range of customer, operational, project or service activities within own team and other related teams
• Manage complex processes, lead the work of small project teams, Formally train and act as a resource for colleagues with less experience
• Support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs
• Support Design Reviews, Technical Reviews, and Gate Reviews
• Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process, and application FMEAs
• Author or review for approval other Risk Management Documentation: PSRA, Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis (BRA)
• Support Internal partners in the development of products; including review and approval of development documentation such as product requirements, schematics, verification, and validation strategy/execution
• Coordinate, review and approve development documentation created by external partners
• Lead implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer
• Maintains knowledge of and applies statistical analysis to support data-driven decision making
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results
• Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary
• Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits as an NPD and/or Sustaining/Remediation subject matter expert
• Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs to support development and sustaining/remediation projects
• Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
• Identify and implement opportunities for continuous improvement in the quality system
• Interact and coordinate activities with other departments, external vendors, and customers.
• Perform other Quality Systems related duties as required.

QA Engineer jobs in New Jersey

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Senior Clinical Quality Assurance Associate

Senior Director, Experience Assurance – UAT, Quality Innovation

Senior Quality Engineering Lead

Quality Assurance Specialist

Senior Specialist, Quality Assurance

Manager, Clinical QA Program Lead

Manager, Clinical QA Program Lead

Quality Assurance Tester II

QA Automation Testing

Staff Source Quality Engineer

Staff Source Quality Engineer

Data Quality Engineer

Staff Quality Assurance Engineer

Lead Quality Engineer

Quality Assurance Technician

Director, Enterprise Quality Engineering

Program Manager, RAQA

QA Performance Claims Specialist

Senior Quality Engineer, Design Assurance

Staff Quality Engineer – Design & Reliability Assurance