Quality Systems Specialist

Company Description Kuro Medical,™ LLC, owned by One Life Sciences™, provides a software and service package that simplifies medical device order fulfillment, inventory tracking, invoicing, and customer support for MedTech and life sciences companies. The Kuro™ platform streamlines operational, logistical, and analytical challenges, with a focus on start-ups and growing organizations. By using a consolidated, FDA/ISO-compliant system, Kuro™ helps customers manage product distribution and customer-facing functions in a scalable and efficient way. One Life Sciences™ is headquartered in Minneapolis, Minnesota, USA, and is dedicated to advancing global health innovation through software and services that improve operational efficiency and capital deployment in healthcare. Role Description The Quality Systems Specialist is a full‑time, on‑site role based in Eden Prairie, MN. This role is responsible for maintaining and improving the company’s quality management system to ensure compliance with FDA, ISO, and other relevant regulatory and industry standards. Day‑to‑day tasks include managing controlled documents, supporting internal audits, monitoring quality metrics, and coordinating corrective and preventive actions (CAPA). The specialist collaborates with cross‑functional teams to review procedures, validate processes, and ensure consistent quality practices across software and service operations. Additional responsibilities may include training team members on quality system requirements and contributing to continuous improvement initiatives. Skills in Quality Management and Quality System development and maintenance, with the ability to ensure compliance and support continuous improvement. Experience in Quality Assurance and Quality Control to monitor processes, evaluate performance, and drive corrective actions. Proficiency in Document Management, including creation, revision, approval, and controlled distribution of quality‑related documentation. Knowledge of FDA and ISO regulations relevant to MedTech and life sciences, and experience working within regulated environments. Strong analytical, organizational, and problem‑solving skills, with attention to detail and accuracy. Effective communication and collaboration skills for working with cross‑functional teams in operations, engineering, and customer support. Bachelor’s degree in a relevant field (such as Quality Management, Life Sciences, Engineering, or a related discipline), or equivalent experience. Experience with quality management systems (QMS) and familiarity with software‑based products or services is beneficial. Perform incoming, in‑process, and final inspection of product, components, and materials per applicable acceptance criteria and inspection plans. Conduct lot history record (LHR) and device history record (DHR) reviews to verify completeness, accuracy, and regulatory compliance. Maintain and reconcile inspection data, acceptance activity logs, and certificate of conformance (CoC) records. Assist with employee training records and controlled forms, as needed. Qualifications Required Associate degree or equivalent combination of education and experience. 2+ years of quality and/or document control experience. Strong organizational and time management skills. Exceptional attention to detail and accuracy. Proficiency in Microsoft Office Suite, particularly Word and Excel. Excellent written and verbal communication skills. Ability to prioritize multiple projects and meet deadlines. Preferred Experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, or manufacturing. Familiarity with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, or ISO 9001. Experience using Document Management Systems. Knowledge of change control and quality management systems. #J-18808-Ljbffr Kuro Medical,™ LLC