Magnolia Medical Technologies is hiring for Quality Engineer to be part of a small and nimble Quality and Regulatory group that is creating revolutionary devices to improve sample collection and integrity for critical in‑vitro diagnostic (IVD) tests. Implementing our Product Reliability Program and managing associated sustaining activities assuring ongoing compliance and professional growth in the medical device and compliance disciplines. Sustaining activities are critical to compliance and are an entry point for product development and improvement. Through a series of product testing, document authorship, and collaboration with multi‑departmental stakeholders from Product Development, Manufacturing Operations, and Quality, this role offers a unique opportunity for career development in a regulated environment.The Quality Engineer is responsible for supporting the development, implementation, and maintenance of the Quality Management System in compliance with FDA, ISO 13485, and applicable global regulatory requirements. This role is highly hands‑on and ideal for someone who thrives in a fast‑paced startup environment and enjoys improving processes.Responsibilities and Duties:Quality System & ComplianceSupport implementation and maintenance of the QMS compliant with ISO 13485, 21 CFR Part 820, and other applicable standardsAuthor, review, and maintain quality documents (SOPs, work instructions, forms, records)Support internal and external audits, including FDA inspections and notified body auditsAssist with Management Reviews and quality metrics reportingDesign & Development SupportSupport Design Controls activities (requirements, risk management, verification & validation)Participate in risk management (ISO 14971) activities, including FMEA and hazard analysisReview design documentation for compliance and completenessAssist as needed with Test and InspectionManufacturing & Supplier QualityReview and approve process validation, including IQ/OQ/PQ activitiesAssist and/or lead supplier qualification, audits, and supplier corrective actionsReview incoming inspection plans and ensure manufacturing controls are effectiveCAPA, NC, and Continuous ImprovementManage complaint handling procedureLead or support CAPA, nonconformance, and deviation investigationsPerform root cause analysis and verify effectiveness of corrective actions, both QMS and customer complaintsDrive continuous improvement across quality processesExperience and Qualifications:Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related field2–5 years of quality engineering experience in the medical device or regulated industryWorking knowledge of ISO 13485, FDA QSR (21 CFR 820), and design controlsExperience with CAPA, audits, document control, and risk managementStrong written and verbal communication skillsPreferred Qualifications:Experience in an early‑stage or startup environmentFamiliarity with ISO 14971, MDR, or global regulatory requirementsExperience supporting V&V, process validation, or supplier auditsCQE, CQA, or similar certificationAbout Magnolia MedicalMagnolia Medical Technologies, Inc. is redefining the accuracy of sepsis testing with Steripath®, the only device proven to reduce blood culture contamination significantly. With over 20 clinical studies, peer‑reviewed publications, and an expanding IP portfolio, Magnolia Medical is establishing the new standard for blood culture integrity. The company offers competitive compensation, benefits, and incentive opportunities in a fast‑growing, mission‑driven environment.#J-18808-Ljbffr