Quality Engineer Technician

Quality Engineer TechnicianMinnetonka, Minnesota, United StatesPartsSource is the leading technology and software platform for managing mission-critical healthcare equipment. Trusted by over 5,000 US hospitals and 15,000 clinical sites, PartsSource empowers providers and service organizations to maximize clinical availability for patient care and automates the procurement of parts, services and training through a unique digital experience.PartsSource team members are deeply committed to our mission of Ensuring Healthcare is Always On®, which is foundational to our success and growth. Our vibrant culture is built upon aligned values, shared ownership, mutual respect, and a passion for collaborating to solve complex customer problems.The Quality Engineer/Technician is a strategic and hands-on quality operations role responsible for overseeing and supporting the organization's Quality Management System (QMS), product testing, and compliance initiatives. This position combines quality systems oversight with direct operational involvement in product testing, returns management, and quality assurance activities. The Quality Engineer develops and maintains quality policies, performs Form, Fit, and Function testing, manages the full lifecycle of returns, analyzes quality data, and ensures compliance with applicable regulatory standards. Reporting to the VP of Quality Assurance, this role bridges quality strategy with day-to-day operations, identifying trends, recommending improvements, and serving as a key resource for both quality leadership and operational teams.What You Will DoKey ResponsibilitiesQuality Systems & ComplianceDevelop and maintain quality assurance policies, standard operating procedures (SOPs), and QMS-related logs and documentationSupport implementation of quality standards within document management systems and ensure proper version controlEnsure adherence to procedures for complaint handling, recalls, returns, reprocessing, and environmental monitoringMaintain compliance with ISO 9001, ISO 13485, 21 CFR 820, cGMP, FDA, and OSHA regulationsSupport the organization's ISO certification maintenance and regulatory audit readinessProduct Testing & Quality AssurancePerform hands-on Form, Fit, and Function (FFF) testing of OEM and compatible products to validate performance, fit, and interchangeabilityDocument all test results in a clear, structured format, capturing pass/fail outcomes, observations, and deviations from specificationsMaintain organized testing logs and ensure findings are accurately entered into internal systems and ERP/WMS platformsParticipate in and manage lot testing programs; review periodic lot testing reports and escalate findings as appropriateFlag product quality concerns and discrepancies to the VP of Quality with supporting documentationReturns Management & DispositionManage the end-to-end returns process, including intake, logging, triage, testing, and disposition of returned itemsTest all returned products against claimed return reasons and document outcomes in accordance with quality standardsDistinguish between valid warranty claims and products outside warranty criteria; escalate borderline cases appropriatelyUpdate internal systems with return testing results, disposition decisions, and quality codesIdentify patterns and trends in return reasons and communicate recurring issues for corrective actionAudits & Supplier ManagementSupport and document internal audits and other quality activitiesCoordinate external audits and supplier on-site assessmentsManage supplier corrective action requests (SCARs) and support collection of supplier quality dataSupport Quality Management Reviews and communicate findings to relevant stakeholdersData Analysis & Quality ImprovementCompile and analyze quality data including test results, return rates, and operational metricsDevelop SOPs for quality data recording, reporting, and risk management activitiesIdentify QMS trends and patterns; recommend process improvements to strengthen overall qualityRecommend and monitor corrective and preventive actions (CAPA)Prepare quality metrics reports and present findings in internal quality meetingsOperational Metrics & Performance TrackingMonitor and track operational performance metrics such as same-day shipping rates, test turnaround times, and quality KPIsIdentify root causes when quality or operational targets are missedSupport continuous improvement initiatives and provide coaching to warehouse and operations staff on quality expectationsReport metrics and performance data to quality leadership and support cross-functional quality initiativesTraining & CommunicationIdentify training needs and support development of quality-related training initiatives for staffCommunicate complex quality issues clearly to management, operations teams, and other stakeholdersPlan and facilitate internal quality meetings, preparing agendas and distributing summariesProvide clear written and verbal communication of quality findings to both technical and non-technical audiencesGeneral SupportAddress daily quality-related questions and operational concernsSupport implementation and verification of corrective actionsPerform additional quality-related tasks assigned by the VP of Quality AssuranceWhat You Will BringEducation & ExperienceA.S. in a science, technical, or business discipline; or 2-3 years of equivalent hands-on quality, quality control, or technical experienceHelpful experience drafting and authoring SOPsDemonstrated experience testing products and documenting results in a structured formatExperience managing quality returns or RMA processDemonstrated cross-functional quality engagement with operations, warehouse, and product teamsKnowledge & SkillsKnowledge of ISO 9001:2015; familiarity with ISO 13485:2016, 21 CFR 820, and cGMP requirementsHands-on technical aptitude and comfort performing physical product testing and inspectionStrong analytical, critical thinking, and problem-solving abilitiesExcellent written and verbal communication skillsHighly organized with strong attention to detail and commitment to accurate documentationProficiency with Microsoft Office (Excel, Word, Outlook); ability to work within ERP/WMS systems for data entry and reportingAbility to manage multiple workstreams simultaneously (testing queues, returns, reporting, meetings)Preferred QualificationsExperience in quality auditingBenefits & PerksCompetitive compensation package with salary, incentives, company ownership/equity, and comprehensive benefits (401k match, health, college debt reduction, and more!)Career and professional development through training, coaching and new experiences.Hybrid culture with new & beautiful workspaces that balance flexibility, collaboration, and productivity.Inclusive and diverse community of passionate professionals learning and growing together.Interested? We'd love to hear from you! Submit your resume and an optional cover letter explaining why you'd be a great fit.About PartsSourceSince 2001, PartsSource has evolved into the leading technology and software platform for managing mission-critical equipment, serving over half of the U.S. hospital infrastructure. Our digital systems modernize and automate the procurement of parts, services, technical support, and training for HTM professionals to efficiently and effectively maintain their mission-critical equipment. PartsSource employs over 700 employees nationwide that committed to supporting healthcare providers and ensuring healthcare always on.In 2021, Bain Capital invested in the business, further accelerating our growth and positive impact within the healthcare industry.EEOPartsSource, Inc., and its affiliates and subsidiaries, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This