QA Engineer

• Lead, identify, develop and implement the business strategy for the Quality department
• Develop and agree upon operating procedures and business processes
• Lead executive and senior management team meetings
• Review audit reports, including process, project and vendor audits, as applicable
• Maintain and develop organizational culture, values and reputation
• Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department
• Support regulatory authority inspections as needed
• Represent the Quality organization in key meetings, including Monthly Business Reviews and Board meetings
• Monitor and assure client satisfaction on existing Quality department projects
• Identify key accounts and maintain strong, long-lasting relationships to win new and repeat business
• Lead the strategic vision, operations and financial health of the Quality organization
• Oversee planning, preparation and execution of customer audits and inspections
• Lead approaches for quality KPIs and metrics in accordance with SOPs, regulatory guidelines, executed client contracts and client expectations
• Participate in the Allucent Leadership team

VP – Quality Assurance

• Define test cases and report test results
• Design, code, and execute automated GUI tests using Selenium WebDriver and C# unit tests
• Design, code, and execute functional automated API tests on REST services using C# Rest Sharp
• Define and execute functional manual test scenarios and scripts that are difficult to automate
• Identify, retest, and report defects
• Support the definition of test plans and user acceptance testing activities
• Support system integrations through implementation and testing of REST web service API integrations
• Integrate and closely cooperate with a major client’s IT team on-site

Test Analyst

• Verantwoordelijk voor het waarborgen en continu verbeteren van de productkwaliteit
• Uitvoeren en coördineren van kwaliteitscontroles, waaronder AQL-inspecties
• Volgen en interpreteren van verpakkingswet- en regelgeving, waaronder de EU Packaging and Packaging Waste Regulations (PPWR)
• Monitoren en opvolgen van leveranciersprestaties op het gebied van kwaliteit
• Beoordelen en evalueren van productmonsters
• Begeleiden van testproducties van nieuwe verpakkingsmaterialen
• Onderzoeken van kwaliteitsissues en analyseren van oorzaken (root cause analysis)
• Initiëren en implementeren van corrigerende en preventieve maatregelen (CAPA)
• Beheren en up-to-date houden van kwaliteitsdocumentatie en verpakkingsdossiers
• Coördineren en afhandelen van klachten, inclusief communicatie met stakeholders
• Signaleren van verbeterkansen en bijdragen aan optimalisatie van processen
• Nauw samenwerken met leveranciers en interne teams om hoge kwaliteitsstandaarden te waarborgen

Senior Quality Specialist – QA

• Provide QA support and oversight for validation and qualification of equipment, automation, processes and information systems
• Review and approve validation and qualification documentation for GMP, regulatory, corporate and site compliance
• Define and challenge validation strategies with Engineering, Manufacturing, Product Development and Information Systems
• Provide QA guidance during design, characterization, commissioning, qualification and validation
• Support CSV and computer system compliance
• Review protocols, reports, risk assessments and technical documentation
• Review and approve technical changes to equipment and engineering procedures
• Apply a risk-based approach to technical and engineering changes
• Provide QA oversight for device and combination-product activities
• Act as QA representative in Quality Risk Management activities
• Facilitate or contribute to FMEA, risk assessments and equipment/automation criticality assessments
• Perform final QA review of technical change controls and coordinate relevant QA input
• Assess changes for impact on validation, GMP, data integrity and compliance

• Bridge QA, production, development, and management by turning test results into risk, status, and clear go/no-go advice
• Represent QA internally and externally, explain QA practices, and uphold standards with external partners and platform holders
• Manage the QA team through 1-on-1s, growth, workload management, and hiring
• Weigh quality risk against business objectives and support or reject calculated risks appropriately
• Plan QA capacity across parallel projects and releases and escalate quality risks early
• Own quality reporting, including release readiness, coverage, bug trends, and roadmap implications
• Challenge the team and identify opportunities that may be overlooked
• Help determine where AI accelerates testing while preserving strong QA fundamentals
• Work closely with the QA Lead Specialist, sharing complementary lead responsibilities and split line management/reporting