QA Engineer

• **About the role **
• An exciting opportunity has opened up for a QA Lead within the QA Team at Davy. This role is ideal for an experienced QA professional who thrives in a fast-paced environment, enjoys solving complex challenges, and can deliver high-quality outcomes within tight deadlines.
• The successful candidate will be a collaborative leader with a strong quality mindset, capable of taking ownership of testing across multiple initiatives while driving continuous improvement in quality practices. They will work closely with business and technology stakeholders to ensure quality is embedded throughout the Software Development Lifecycle (SDLC).
• In the role, the successful candidate will:
• - Develop a deep understanding of the business domain, customer needs, and regulatory requirements within financial services.
• - Act as the primary QA contact for both business and technical stakeholders.
• - Define, shape, and continuously evolve the overall testing strategy and approach.
• - Champion quality across the full software delivery lifecycle, ensuring testing is considered from the earliest stages of delivery.
• - Drive process improvements and promote best practices across teams.
• - Balance hands-on testing activities with leadership, mentoring, and strategic initiatives.
• - Lead, coach, and support QA team members, fostering a culture of collaboration and continuous improvement.
• - Review and analyse business requirements, technical specifications, and solution designs to ensure testability and quality.
• - Identify and assess risks, prioritise testing efforts accordingly, and proactively communicate issues and mitigation strategies.
• - Define, track, and report on quality metrics and release readiness indicators.
• - Promote shift-left testing, test automation, quality engineering, and reusable test assets.
• - Relational database query development using SQL, DB2, or equivalent query languages.
• - Support the adoption of AI-enabled testing practices and innovative testing solutions.
• - Contribute to automation initiatives using tools such as Rational Functional Tester (RFT), TestComplete, or equivalent technologies.

QA Lead

• Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, Root cause analysis, CAPAs and change controls
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
• Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
• Actively participate in Plant/Quality committees and collaborate with other site functional groups.

Quality Assurance Specialist

• Lead, conduct, and support investigations of Product Quality Complaints (PQCs) for commercial and clinical products
• Help ensure investigations are complete, scientifically sound, and appropriately documented within the Product Quality Complaint database
• Evaluate technical information to ensure appropriate analyses, investigations, and failure mode assessments have been performed and documented before complaint closure
• Support Product Quality Vigilance projects, new business initiatives, and complaint management processes
• Serve as a key partner to manufacturing sites and multi-functional teams
• Serve as a key Product Quality Vigilance contact for assigned manufacturing sites, supporting investigation activities, complaint management processes, issue escalation, and product knowledge transfer
• Participate in failure investigations, Medical Device Reporting activities, and product trend evaluations
• Collaborate with Manufacturing Sites, Product Development Managers, Contact Centers, Global Medical Safety, Marketing, Sales Administration, Brand Protection, Engineering Quality, Product Quality Management, and other partners to strengthen investigation activities, share product knowledge, and support complaint handling processes throughout the product lifecycle.
• Create and maintain work instructions and standard operating procedures related to complaint investigations and complaint management activities.

Senior Quality Investigation Engineer

• Ensure the quality of the work is maintained and inspection-ready in accordance with internal and external cGxP requirements and expectation
• Ensure adherence to GMP, EU Annex 1, FDA, and other applicable regulatory guidelines
• Support the cross-function readiness for batch certification, ensuring all documentation related to the team is finalised within a timely manner
• Ensure the team is in compliance with all Training and Health & Safety requirements, in accordance with company policy
• Provide the team’s performance status with regular interaction with cross-functional peers and management, as defined via tier/triage-structures
• Support the success of inter-team and cross-team KPIs to ensure performance is measurable for the function’s goals and objectives, aligned with the departmental strategic objectives
• Support the team’s organisational structuring and provide general direction to ensure the team is successful in handling day-to-day operations
• Ensure the team is adequately trained to cover the full scope of responsibilities, and develop training (internal and external), where applicable, to ensure quality and technical competencies
• Be the functions’ ‘voice’ / point-of-contact for the teams to ensure appropriate distribution of communication (given & received)
• Support resource management (capacity model & hiring process) to aid departmental objectives and business requirements
• Deputise for cross-shift peer Team Leads, and/or the Supervisor, as required
• Provide operational leadership to navigate the teams, inclusive of Analysts and Specialists, including coaching, mentoring, performance management, professional development, and objective setting
• Manage the team’s routine activities, ensuring they are scheduled, performed, and completed within agreed timeframes and in accordance with procedures and regulations
• Activities are inclusive of: QA Shop Floor: Leading the ‘Quality Culture’ to the manufacturing operation, through on-the-job coaching and mentoring in aseptic manufacturing, inclusive of adhering to aseptic principles, behaviours, and overall aseptic manufacturing controls in-situ (e.g., Gowning, Disinfection)
• Performing daily GEMBAs and facility walk-through audits of the manufacturing areas, from Grade A critical interventions to Grade B, C, and D supporting activities
• Support the decision-making process in atypical event handling on the floor, inclusive of aseptic intervention and maintenance activities
• Support the manufacturing in-process control (IPC) and end-of-batch reconciliation processes, ensuring the manufacturing operation is compliant to the defined batch records and procedures
• Support air visualization studies (smoke studies) and aseptic process simulations to develop and maintain aseptic principles and behaviours
• Supporting the deviation, investigation, CAPA, and change lifecycle, in collaboration with the wider QA functions
• Authoring, reviewing, and approving documentation, inclusive of MBRs, Risk Assessments, SOPs, and Training, as required
• KPI monitoring, specifically focused on personnel aseptic behaviours, Grade A & B qualifications, and deviations associated to lapses in the defined contamination controls
• QA Environmental Monitoring: Performing viable, total particulate (non-viable), water systems, and gas monitoring throughout Grade A, B, C, and D classified areas
• Supporting the deviation, investigation, and CAPA lifecycle, including impact analysis and overall quality robustness and effectiveness associated to Environmental Monitoring excursions
• Authoring, reviewing, and approving documentation, inclusive of Risk Assessments, SOPs, Training, and Records, as required
• Support environmental data analysis to generate periodic trending reports for overall facility evaluation and impact
• Support the overall contamination control strategy from an EM perspective, including sampling methodologies and techniques
• Foster a strong stakeholder collaboration with other core QA and MFG functions to ensure quality compliance standards are adhered to
• Foster a LEAN attitude to create a pro-active continuous improvement culture within the team and support the facilitation of ‘Quality Mindset’ throughout
• Provide feedback to the team to facilitate professional development and foster an ‘open-door’ culture
• Any other duties as required, following consultation with the post holder
• Provide technical expertise, predominantly focused on regulations for aseptic manufacture, and environmental monitoring execution, presented in the form of coaching, mentoring and presentations for stakeholder understanding
• Participate in risk assessments or strategic decision meetings and act as an SME to ensure either new or modified processes are appropriately implemented for operational success, under cGMP conditions

QA Team Lead – Shop Floor, Environmental Monitoring

• Perform manual and automated testing for server and client migration
• Design, develop, and maintain automated testing scripts and frameworks
• Identify and prioritize test cases for automation
• Collaborate with teams to review test cases and align activities

Senior QA Engineer

• Conducting extensive penetration tests across networks, applications, cloud environments, and infrastructure
• Scanning the client's external exposure websites and domains to identify security vulnerabilities and performing vulnerability assessments, and providing risk-based remediation recommendations
• Lead Threat-Led Penetration Testing (TLPT) / TIBER engagements
• Utilizing Threat Intelligence methodologies to simulate realistic attack scenarios
• Producing detailed technical reports outlining findings, risk levels, and mitigation strategies
• Collaborating with security teams, SOC analysts, and blue teams to improve defensive strategies
• Staying updated on the latest attack techniques, tools, and industry best practices
• Developing and deploying custom tooling and malware for Red Team engagements
• Guiding and mentoring junior team members

Senior Penetration Tester

• Lead risk-based audit planning across therapeutic areas and studies
• Drive strategic audit programs using risk indicators from study teams
• Ensure audits align with approved programs and scheduled timelines
• Manage audit outcomes to identify trends and communicate risks
• Represent quality assurance on complex cross-functional initiatives
• Deliver reports and metrics to Global Development leadership
• Collaborate effectively with stakeholders across global functions
• Navigate ambiguity while prioritizing multiple complex activities
• 10-20% travel might be required

Senior Manager, QA Auditor, GCP Strategy

• Developing and implementing quality assurance strategies and processes to support clinical trial activities
• Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines
• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed
• Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices
• Contributing to the development and maintenance of quality management systems and documentation

Manager, Quality Assurance – EU Q&C Audit Defense Team

• Conduct audits completed by internal specialists and vendor agents for all lines of business - including email support and moderation. Also conduct other audit types as requested - RCA, Targeted Audits, etc.
• Coach internal specialists and vendor Team Leads and graders on behaviors, workflows, and processes
• Create, maintain, and update rubrics that effectively measure agent performance
• Analyze data to determine how each line of business is performing, as well as present this data to key stakeholders
• Identify areas of opportunity for the team and business through trend analysis
• Work closely with key stakeholders, as well as our internal and external partners
• Build and maintain relationships with our vendor teams to ensure KPIs are being met as well as ensuring accountability when needed
• Execute projects while also ensuring all weekly audits are completed

Quality Assurance Analyst – Global Operations

• Conduct penetration tests and technical security assessments on: Web applications and APIs
• Mobile applications
• Network infrastructure (internal and external)
• Cloud and hybrid environments
• Social engineering scenarios (as needed)
• Consultancy
• Other offensive security services
• Review system architecture and application designs for security weaknesses.
• Exploit and escalate vulnerabilities to demonstrate real-world risk.
• Document technical findings and produce high-quality reports with remediation guidance.
• Stay current with the latest attack techniques, vulnerabilities, and tools.
• Participate in internal knowledge sharing, tool development, and security research.
• Support sales activities with technical insights when needed (e.g., scoping calls, workshops).
• Represent Integrity360 in client engagements, technical discussions, or industry forums.

Penetration Tester

• Ensure end-to-end system functionality across mobile applications, web portals, and backend APIs
• Validate real-time communication features including call quality, stability, and performance
• Design and execute test scenarios for network instability, packet loss, and reconnection flows
• Perform functional testing across authentication, role-based access, dashboards, and API layers
• Identify, document, and track edge cases affecting user experience and system reliability
• Collaborate with engineering teams to reproduce, isolate, and resolve defects
• Contribute to continuous improvement of QA processes and test coverage
• Support regression testing for releases and hotfix deployments.

Senior QA Engineering

• Oversee the end‑to‑end quality program for an assigned product value chain in antibody drug conjugates.
• Be a core member of the Value Chain Management Team, partnering across functions to ensure a reliable supply of high‑quality products throughout their commercial lifecycle.
• Lead end‑to‑end quality oversight for the product program, ensuring compliance with procedures and regulations.
• Develop and maintain the Product Quality Strategy and Product Analytical Strategy in line with supply strategy.
• Partner with Quality, Regulatory, Technical, Supply Chain, and site Quality teams to align priorities and resolve issues.
• Strengthen and harmonize Quality Management Systems and ways of working, sharing best practices across sites.
• Stay current with regulatory requirements, support or lead inspections, and drive ongoing inspection readiness.
• Provide quality leadership to product focus teams, the Value Chain Management Team, and related working groups.
• Lead quality communications across the network, including meetings, updates, and escalation of issues and risks.
• Support analytical siting strategies and broader value‑chain projects, ensuring quality input and follow‑through.
• Track and interpret change control, complaints, and quality performance data to identify trends.
• Review Annual Product Reviews, evaluations, and post‑marketing product reviews to assess and communicate risks.
• Monitor, report and mitigate quality and supply chain risks across the franchise.

Director, Quality Assurance – Value Chain Management

• Establishing and evolving formal QA processes, while ensuring the use of industry-accepted best practices
• Overseeing all aspects of quality assurance including establishing metrics and applying and developing new tools and processes to ensure quality goals are met
• Defining test methods and creating test plans for new or updated software projects to determine if the software will perform accurately and reliably according to documented requirements as well as established standards under both normal and abnormal conditions
• Test planning, execution and reporting
• Acting as the key point of contact for all QA aspects of releases and coordinating QA resources internally and externally
• Leading and mentoring QA team members including regular performance reviews and feedback to foster improvement and career growth

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