Quality Engineer Technician

parts source

Minnetonka (MN)

On-site

USD 70,000 - 95,000

Full time

14 days+

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Benefits offered by this job

401k match

Health benefits

Equity opportunities

Job summary

PartsSource is seeking a Quality Engineer/Technician to oversee quality management systems, perform product testing, and manage returns. This role bridges quality strategy with day-to-day operations, ensuring ISO and regulatory alignment while driving continuous improvement across all processes.

You will maintain QA documentation, support audits, and collaborate with operations to improve product quality and customer outcomes.

Qualifications

A.S. in a science, technical, or business discipline or 2-3 years of quality experience.
Experience drafting SOPs and maintaining QA documentation.
Knowledge of ISO 9001:2015 and 13485:2016, 21 CFR 820, cGMP.

Responsibilities

Develop and maintain quality policies, SOPs, and QMS logs.
Perform hands-on product testing (FFF) and document results.
Manage returns process, dispositions, and quality codes in systems.
Support audits, supplier quality data, and CAPA actions.
Analyze quality data and drive improvements with cross-functional teams.

Skills

Quality systems

ISO 9001/13485

Data analysis

Documentation

ECC/WMS systems

Education

A.S. in science/technical or 2-3 years quality experience

Tools

Microsoft Office

ERP/WMS systems

Job description

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.

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 elevate 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; elevate 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

Benefits & Perks

Competitive compensation package with salary, incentives, company ownership/equity, and comprehensive benefits (401k match, health, college debt reduction,andmore!)

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.

About PartsSource

Since 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 who are 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.