Quality Engineer Technician

PartsSource • Minnetonka, MN

15h • Hybrid

About The Position

PartsSource 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.

Requirements

• A.S. in a science, technical, or business discipline; or 2-3 years of equivalent hands-on quality, quality control, or technical experience
• Helpful experience drafting and authoring SOPs
• Demonstrated experience testing products and documenting results in a structured format
• Experience managing quality returns or RMA process
• Demonstrated cross-functional quality engagement with operations, warehouse, and product teams
• Knowledge of ISO 9001:2015; familiarity with ISO 13485:2016, 21 CFR 820, and cGMP requirements
• Hands-on technical aptitude and comfort performing physical product testing and inspection
• Strong analytical, critical thinking, and problem-solving abilities
• Excellent written and verbal communication skills
• Highly organized with strong attention to detail and commitment to accurate documentation
• Proficiency with Microsoft Office (Excel, Word, Outlook); ability to work within ERP/WMS systems for data entry and reporting
• Ability to manage multiple workstreams simultaneously (testing queues, returns, reporting, meetings)

Nice To Haves

• Experience in quality auditing

Responsibilities

• Develop and maintain quality assurance policies, standard operating procedures (SOPs), and QMS-related logs and documentation
• Support Implementation of quality standards within document management systems and ensure proper version control
• Ensure adherence to procedures for complaint handling, recalls, returns, reprocessing, and environmental monitoring
• Maintain compliance with ISO 9001, ISO 13485, 21 CFR 820, cGMP, FDA, and OSHA regulations
• Support the organization's ISO certification maintenance and regulatory audit readiness
• Perform hands-on Form, Fit, and Function (FFF) testing of OEM and compatible products to validate performance, fit, and interchangeability
• Document all test results in a clear, structured format, capturing pass/fail outcomes, observations, and deviations from specifications
• Maintain organized testing logs and ensure findings are accurately entered into internal systems and ERP/WMS platforms
• Participate in and manage lot testing programs; review periodic lot testing reports and escalate findings as appropriate
• Flag product quality concerns and discrepancies to the VP of Quality with supporting documentation
• Manage the end-to-end returns process, including intake, logging, triage, testing, and disposition of returned items
• Test all returned products against claimed return reasons and document outcomes in accordance with quality standards
• Distinguish between valid warranty claims and products outside warranty criteria; escalate borderline cases appropriately
• Update internal systems with return testing results, disposition decisions, and quality codes
• Identify patterns and trends in return reasons and communicate recurring issues for corrective action
• Support and document internal audits and other quality activities
• Coordinate external audits and supplier on-site assessments
• Manage supplier corrective action requests (SCARs) and support collection of supplier quality data
• Support Quality Management Reviews and communicate findings to relevant stakeholders
• Compile and analyze quality data including test results, return rates, and operational metrics
• Develop SOPs for quality data recording, reporting, and risk management activities
• Identify QMS trends and patterns; recommend process improvements to strengthen overall quality
• Recommend and monitor corrective and preventive actions (CAPA)
• Prepare quality metrics reports and present findings in internal quality meetings
• Monitor and track operational performance metrics such as same-day shipping rates, test turnaround times, and quality KPIs
• Identify root causes when quality or operational targets are missed
• Support continuous improvement initiatives and provide coaching to warehouse and operations staff on quality expectations
• Report metrics and performance data to quality leadership and support cross-functional quality initiatives
• Identify training needs and support development of quality-related training initiatives for staff
• Communicate complex quality issues clearly to management, operations teams, and other stakeholders
• Plan and facilitate internal quality meetings, preparing agendas and distributing summaries
• Provide clear written and verbal communication of quality findings to both technical and non-technical audiences
• Address daily quality-related questions and operational concerns
• Support implementation and verification of corrective actions
• Perform additional quality-related tasks assigned by the VP of Quality Assurance

Benefits

• Competitive 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree