Quality Engineer Technician

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 Do

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

What You Will Bring

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