Quality Engineer Technician

Key Responsibilities 

Quality Systems & Compliance 

• →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 

Product Testing & Quality Assurance 

• →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 

Returns Management & Disposition 

• →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 

Audits & Supplier Management 

• →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 

Data Analysis & Quality Improvement 

• →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 

Operational Metrics & Performance Tracking 

• →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 

Training & Communication 

• →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 

General Support 

• →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 

Education & Experience 

• →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 & Skills 

• →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) 

Preferred Qualifications 

• →Experience in quality auditing 

· PartsSource Named to Newsweek’s List of the Top 200 America’s Most Loved Workplaces for 2024

· PartsSource® Named Among the Top 50 Healthcare Technology Companies of 2025

· PartsSource® Named Among the Top 25 Healthcare Software Companies of 2025

· PartsSource President and CEO Philip Settimi Named to Top 50 Healthcare Technology CEO List 2025

· WSJ: Bain Capital Private Equity Scoops Up PartsSource

Legal authorization to work in the U.S. is required.