Design Quality Engineer

Ensure products developed by Biokit meet all Quality requirements and comply with applicable regulationsProvide quality oversight for development and commercialization of new assay products and post-commercialization design changesProvide Design Control and Design Change Control guidance, including risk management and regulatory strategiesEnsure assays comply with the Product Development process, Biokit Quality System, and worldwide design control regulationsPrepare documentation supporting worldwide regulatory submissions, product risk management, and design historyCollaborate with R&D, Quality Operations, Regulatory Affairs, and Operations to meet project goals and complete regulatory submissionsApply a risk-based approach to validation and implementation of product changesProvide Quality Oversight to non-conformance investigations, root cause investigations, and CAPAEnsure documentation is QA reviewed before sharing with regulators or customersLead continuous improvement of DQ processes, standards, tools, and techniquesDesign and deliver training on design controlCollaborate with QRA, R&D, and Operations for successful Regulatory InspectionsRequirementsBachelor’s degree (Diplomatura) in Life Sciences, Engineering, or Physical Science; relevant skills and work experience may substitute for the degreeMinimum of 3 years in a similar positionFluency in Office Tools (Excel & Word)Basic knowledge in SAP is valuableFluency in Spanish or CatalanAdvanced knowledge of English (reading and speaking)Knowledge of Quality standards, including design control and validationCertifications such as ASQ-CQA, ASQ-CQE, ASQ-SWQE, ASQCQM, Process Excellence are valuableAbility to manage decisions under pressureMethodical and well-organizedTime management skillsAbility to express information clearly and conciselyAbility to apply a systematic approach and control, follow up, and verify resultsAbility to collaborate, participate, and coordinate actively with working groupsCore CompetenciesDemonstrates expertise in Quality Oversight, Design Control, and regulatory compliance for assay products, with a strong focus on risk management and continuous improvement processes.Proficient in collaborating across departments to ensure successful regulatory submissions and adherence to quality standards.Highest-signal resume keywordsQuality OversightDesign ControlRegulatory ComplianceRisk ManagementContinuous ImprovementHard SkillsQuality StandardsDesign Change ControlValidationRegulatory SubmissionsDocumentation PreparationRoot Cause InvestigationCAPAProject ManagementAssay DevelopmentProduct Risk ManagementSoft SkillsTime ManagementMethodical OrganizationClear CommunicationCollaborationDecision-Making Under PressureCertifications & QualificationsASQ-CQAASQ-CQEASQ-SWQEASQCQMProcess ExcellenceIndustry KeywordsBiokit Quality SystemWorldwide Design Control RegulationsNon-Conformance InvestigationsRegulatory InspectionsAssay ProductsTools & TechnologiesOffice ToolsExcelWordSAP#J-*****-Ljbffr

processes, standards, tools, and techniquesDesign and deliver training on design controlCollaborate with QRA, R&D, and Operations for successful Regulatory InspectionsRequirementsBachelor’s degree (Diplomatura) in Life Sciences, Engineering, or Physical Science; relevant skills and work experience may substitute for the degreeMinimum of 3 years in a similar positionFluency in Office Tools (Excel & Word)Basic knowledge in SAP is valuableFluency in Spanish or CatalanAdvanced knowledge of English (reading and speaking)Knowledge of Quality standards, including design control and validationCertifications such as ASQ-CQA, ASQ-CQE, ASQ-SWQE, ASQCQM, Process Excellence are valuableAbility to manage decisions under pressureMethodical and well-organizedTime management skillsAbility to express information clearly and conciselyAbility to apply a systematic approach and control, follow up, and verify resultsAbility to collaborate, participate, and coordinate actively with working groupsCore CompetenciesDemonstrates expertise in Quality Oversight, Design Control, and regulatory compliance for assay products, with a strong focus on risk management and continuous improvement processes. Proficient in collaborating across departments to ensure successful regulatory submissions and adherence to quality standards.Highest-signal resume keywordsQuality OversightDesign ControlRegulatory ComplianceRisk ManagementContinuous ImprovementHard SkillsQuality StandardsDesign Change ControlValidationRegulatory SubmissionsDocumentation PreparationRoot Cause InvestigationCAPAProject ManagementAssay DevelopmentProduct Risk ManagementSoft SkillsTime ManagementMethodical OrganizationClear CommunicationCollaborationDecision-Making Under PressureCertifications & QualificationsASQ-CQAASQ-CQEASQ-SWQEASQCQMProcess ExcellenceIndustry KeywordsBiokit Quality SystemWorldwide Design Control RegulationsNon-Conformance InvestigationsRegulatory InspectionsAssay ProductsTools & TechnologiesOffice ToolsExcelWordSAP#J-*****-Ljbffr