Director of Quality Assurance & Risk

Director of Quality Assurance & Risk WoundVision | Medical Device & Healthcare TechnologyLead compliance. Elevate quality. Drive impact.At WoundVision, we’re redefining how healthcare providers assess and manage wounds through innovative technology. To support our continued growth, we’re looking for a Director of Quality Assurance & Risk who will take ownership of our quality and compliance function—ensuring our products, systems, and processes that meet the highest standards in a regulated environment.This is a hands-on leadership role for someone who thrives in detail, understands complex regulatory landscapes, and can drive quality initiatives across teams. You’ll play a critical role in maintaining compliance with FDA regulations, IEC 60601 standards, and SOC 2 frameworks, while shaping the future of our quality systems.What You’ll Own & DriveLead and execute quality inspections, audits, and testing activities to ensure compliance with company and regulatory standardsOwn and enhance the Quality Management System (QMS), including documentation, procedures, and recordsDrive compliance initiatives across FDA (21 CFR Part 820), IEC 60601, and/or SOC 2 requirementsEvaluate manufacturing, operational, and documentation processes for quality adherence and continuous improvementLead and support internal and external audits, including preparation and response activitiesInvestigate non-conformances, deviations, and customer complaints and implement effective CAPA solutionsPartner cross-functionally with engineering, manufacturing, IT, operations, and regulatory teams to resolve quality challengesMonitor and report on quality metrics to support leadership decision-makingEnsure rigorous document control, traceability, and retention practicesSupport supplier quality and vendor compliance assessments when applicableParticipate in (and elevate) risk assessments and continuous improvement initiativesWhat You BringBachelor’s Degree in quality assurance, Engineering, Life Sciences, Information Systems, or related field preferred5+ years of experience in quality control, quality assurance, regulatory compliance, or similar rolesWorking knowledge of FDA regulations, including 21 CFR Part 820Experience with IEC 60601 standards and testing requirements (preferred)Experience supporting SOC 2 compliance, audits, and controls (preferred)Strong expertise in CAPA processes, root cause analysis, and audit managementDeep understanding of QMS systems and documentation best practicesExcellent analytical thinking, organization, and problem-solving skillsStrong written and verbal communication skillsProficiency with Microsoft Office and quality/document management systemsWhat Sets You ApartASQ certification (CQE, CQA, or similar)Experience in medical devices, healthcare technology, SaaS, or regulated manufacturingKnowledge of ISO 13485, ISO 27001, or similar frameworksExperience working with third-party auditors and regulatory agenciesKey Strengths for SuccessSharp attention to detailDeep regulatory and compliance knowledgeStrong critical thinking and root cause analysis skillsHigh level of documentation accuracyCollaborative mindset with clear communicationExcellent time management and organizational skillsWhat We OfferCompetitive salary based on experienceComprehensive health, dental, and vision insuranceGenerous paid time off and holidaysRetirement plan optionsOngoing professional development and certification supportIf you’re ready to lead quality in a growing healthcare technology company and make a real impact, we want to hear from you.WoundVision is an Equal Opportunity Employer. We encourage applications from all qualified individuals without regard to race, color, religion, gender, sexual orientation, age, national origin, marital status, citizenship, disability, or veteran status.