Senior Quality Systems Specialist

Build a Career That Makes an ImpactAt huMannity Medtec, you don't just build a career, you help change lives.For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world.We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work.Why huMannity Medtec? Mission-driven work that impacts lives A 9/80 schedule with every other Friday off (26 long weekends a year!) Collaborative teams solving complex challenges Opportunities to learn, grow, and make an impact Weekly team traditions, monthly lunches, and quarterly events that bring us togetherPosition SummaryWe are seeking an experienced Senior Quality Systems Specialist to support and continuously improve our Quality Management System (QMS) while ensuring compliance with ISO 13485:2016, applicable regulatory requirements, and company quality objectives.This role serves as a Quality Systems Subject Matter Expert (SME), partnering with Research & Development, Manufacturing, Quality Assurance, and cross-functional teams to promote a culture of quality and compliance throughout the organization. The ideal candidate is highly organized, detail-oriented, and passionate about building effective quality systems that support operational excellence, audit readiness, and continuous improvement.Essential Duties and ResponsibilitiesQuality Management System (QMS)Develop, implement, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, regulatory requirements, and company procedures.Serve as the Quality Systems Subject Matter Expert (SME) and provide guidance on quality system requirements and best practices.Develop, revise, and maintain SOPs, work instructions, forms, templates, and other controlled documents.Review and approve quality system documentation to ensure consistency, accuracy, and compliance.Audits & Regulatory CompliancePlan, schedule, coordinate, and conduct the internal audit program.Prepare audit reports, communicate findings, and support follow-up activities.Serve as the primary coordinator and host for external audits, including ISO certification and surveillance audits.Support organizational audit readiness by preparing documentation and coordinating cross-functional activities.Track audit observations and nonconformances through closure and effectiveness verification.CAPA & Continuous ImprovementSupport the CAPA program by facilitating investigations, root cause analysis, corrective actions, and effectiveness checks.Collaborate with cross-functional teams to resolve quality system issues and improve compliance.Lead QMS improvement projects and process optimization initiatives.Identify opportunities to improve efficiency, effectiveness, and overall quality system performance.Quality Metrics & Management ReviewDevelop, monitor, analyze, and report Quality Objectives, KPIs, and quality system metrics.Create dashboards, trend analyses, and reports to support decision-making and continuous improvement activities.Lead preparation of Management Review materials by collecting and analyzing quality system data.Present trends, metrics, and recommendations that support executive review and business objectives.Training & Cross-Functional SupportProvide guidance, coaching, and training on quality system requirements, processes, and procedures.Partner with Manufacturing, Engineering, Quality Assurance, and R&D teams to promote compliance and process consistency.Support company-wide initiatives that strengthen quality culture and operational excellence.Act as a resource for interpreting quality system requirements and regulatory expectations.Required QualificationsBachelor's degree or equivalent combination of education and experience.Minimum of 10 years of combined practical and educational experience within the medical device industry.Hands-on experience maintaining and improving Quality Management Systems.Strong working knowledge of ISO 13485:2016 requirements.Excellent technical writing, documentation, and communication skills.Experience developing and maintaining SOPs, work instructions, forms, and controlled documents.Experience planning, conducting, and supporting internal and external audits.Strong analytical, organizational, and problem-solving skills.Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and database systems.Ability to manage multiple priorities and work independently.Ability to quickly understand complex processes and quality system requirements.Preferred QualificationsExperience serving as a Quality Systems SME in a medical device environment.Experience leading ISO certification, surveillance, and regulatory audits.Working knowledge of FDA Quality System Regulations (QSR/QMSR).Experience supporting CAPA, nonconformance, and quality improvement programs.Experience developing quality metrics, dashboards, and management review presentations.Experience leading cross-functional quality system improvement initiatives.Strong understanding of risk-based quality management principles.Work EnvironmentOffice-based environment with regular interaction across Manufacturing, Engineering, Quality, and R&D teams.Frequent participation in audits, management reviews, and cross-functional quality activities.Fast-paced environment supporting multiple projects and organizational priorities.Physical RequirementsAbility to remain in a stationary position while working at a computer for extended periods.Ability to occasionally move throughout office and manufacturing environments.Ability to communicate effectively with employees, auditors, and business partners.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position