Quality Assurance Specialist

Quality Systems LeadAt Drucker Diagnostics, we know that making people healthier starts with information. Behind every diagnostic test result is a patient waiting to learn what comes next. Our benchtop centrifuges prepare the samples that guide critical healthcare decisions, from routine bloodwork to urgent diagnoses, and we support regenerative therapies like Platelet-Rich Plasma treatments. When accuracy matters most, laboratories and clinics in over 80 countries trust the instruments we design and build right here in the USA.Every component we create, every centrifuge system we design, and every person on our team plays a role in delivering results that healthcare providers can act on with confidence. That's the responsibility we carry, and it drives everything we do. If you want to build something truly remarkable, something that helps people get the answers they need, join us.As the Quality Systems Lead, you will play a key role in protecting the quality, safety, and reliability of the products we manufacture while strengthening the systems and processes that support them. You will serve as a Quality Management System (QMS) process owner and work across the organization to ensure our quality systems remain compliant, effective, and continuously improving.Through quality investigations, CAPA, risk management, audits, process validation, change review, and data-driven improvement, you will help identify issues before they become problems and drive sustainable solutions when improvements are needed. Working closely with Engineering, Manufacturing, Suppliers, and other functional teams, you will help ensure that quality is built into our products and processes, not simply inspected at the end.Your work directly supports our mission of Making People Safer, Healthier, and More Productive by helping ensure the medical devices our customers depend on consistently meet the high standards they expect from Drucker Diagnostics.Quality Management System & ComplianceServe as the Quality System process owner for designated QMS elements, ensuring ongoing compliance, effectiveness, and continuous improvement.Develop, maintain, and continuously improve the Quality Management System, policies, and procedures in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.Participate in and support internal, customer, regulatory, and certification audits of the Quality Management System.Support organizational compliance with applicable federal, state, local, and industry regulations, standards, and internal policies.Review and approve product, process, and quality system changes to ensure appropriate quality and regulatory requirements and risk considerations are addressed.Investigations, CAPA & Risk ManagementFacilitate and conduct quality investigations, identify root causes, and drive effective corrective and preventive actions (CAPAs).Lead the investigation, documentation, and resolution of Quality Control Nonconformances (QCNs).Perform risk assessments and support Risk Management activities in accordance with ISO 14971 throughout the product lifecycle.Drive continuous improvement through defect prevention, stronger process controls, and sustainable corrective actions.Product & Process QualityAssist in the development and maintenance of product quality plans and quality assurance strategies.Partner with Engineering, Manufacturing, and Suppliers to support the consistent delivery of conforming products and processes.Support process validation activities, including protocol review, execution support, and validation documentation.Support Quality Control operations and product quality activities as needed.Quality Improvement & Cross-Functional LeadershipCollaborate across functions to identify, evaluate, and resolve significant quality-related issues.Analyze and report quality system metrics and trends to support management review and informed decision-making.Identify, lead, and support quality improvement initiatives that enhance compliance, operational efficiency, and product quality.Promote a culture of quality, accountability, prevention, and continuous improvement throughout the organization.Promote compliance with applicable safety requirements, regulations, and workplace standards.Maintain and expand professional knowledge through ongoing education, training, and professional development.Perform other duties and responsibilities as assigned.