Quality Specialist

To help us better manage incoming applications, please submit your resume through the Careers section of our website: Quality Specialist, full-time, in-personPuzzle Medical Devices® Inc. is developing a percutaneous heart pump for patients with advanced heart failure. The device’s design allows for safe percutaneous implantation to support both renal and cardiac function through a 4 mm-pump implanted in the descending aorta with a 4 Fr axillary driveline, allowing full patient mobility. To date, Puzzle Medical Devices® Inc. has successfully:Completed 3 financing rounds in 2022, 2023, and 2025;
Completed its first-in-human study with all patients experiencing improvements in cardiac and kidney function from 2022 - 2024;
Grew its team to ~50 people;
Received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in 2021.Position SummaryPuzzle Medical Devices® Inc. is currently seeking a Quality Specialist to support the development, manufacturing, and validation of our percutaneous heart pump system. This role is critical to ensuring that products, processes, and suppliers meet internal quality standards and applicable regulatory requirements.Role And ResponsibilitiesQualify, monitor, and manage suppliers in compliance with internal quality standards and regulatory requirementsReview and approve supplier documentation, certifications, and change notificationsSupport supplier audits, nonconformances, CAPAs, and quality investigationsReview and approve job travelers, work instructions, manufacturing forms and records to ensure accuracy, control, traceability and QMS complianceSupport document control and change management activitiesSoftware Validation & Quality SystemsPlan, execute, and document software and system validation activities (e.G., manufacturing software, test equipment, quality systems)Ensure validation activities comply with ISO 13485 and internal proceduresMaintain validation documentation, traceability, and revalidation assessmentsSupport internal audits, regulatory inspections, and quality reviewsRisk Management & Continuous ImprovementParticipate in risk management activities, including FMEA and process risk assessmentsContribute to continuous improvement initiatives across quality, design and manufacturing processesCross-Functional CollaborationWork closely with R&D, manufacturing, operations, procurement, and regulatory teamsProvide quality guidance throughout the product development and manufacturing lifecycleQualificationsBachelor’s degree (Mechanical, Biomedical, Industrial, or related field)Experience in a regulated environment (medical devices strongly preferred)Knowledge of quality standards and regulations such as ISO 13485, FDA QMSR, and GxP principlesExperience with supplier quality, production documentation, and change controlFamiliarity with software validation principles and documentationStrong attention to detail, organizational skills, and analytical mindsetAbility to communicate clearly and work effectively in a cross-functional, fast-paced environmentBonusExperience supporting manufacturing of implantable or Class II/III medical devicesExperience with audits (internal, supplier, or regulatory)Familiarity with electronic QMS toolsNote: This job description is intended to provide a general overview of the position. It is not an exhaustive list of responsibilities, qualifications, or requirements. The employer reserves the right to modify the duties or requirements of the position as needed.
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