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# Software Quality Engineer

- **Company:** CareerCircle
- **Location:** Minneapolis, MN, United States (Remote available)
- **Salary:** $104,000.0 - $145,600.0
- **Contract:** Temporary contract
- **Skills:** Artificial Intelligence, Software Quality, Document Management Systems, Python (Programming Language), Verification and Validation (Software), Iq/oq/pq, Model Validation
- **Published:** July 10, 2026
- **Apply:** https://www.careercircle.com/jobs/all/all/usa/mn/minneapolis/560f9ebc-6d99-437d-9f9b-e8f8a5553e68

## About the Role

* Experience in software validation and quality assurance.
 * Proficiency in authoring quality records for QMS NPSW.
 * Expertise in regulatory standards such as 21 CFR Part 820 and ISO.
 * Ability to evaluate and provide feedback on quality records.
 * Experience in managing cross-functional teams.

Additional Skills & Qualifications

 * Experience with systems like PLM (Product Lifecycle Management) and ERP (Engineering Resource Planning).
 * Ability to coach and mentor coworkers on compliance.
 * Capability to perform in various approver roles.

Work Environment

The work environment involves managing multiple projects and facilitating cross-functional teams. The role may require adapting to different systems and ensuring compliance with corporate procedures., Problem Solving
Medical Devices
Technical Writing
Health Technology
Electrophysiology
Method Validation
ISO 13485 Standard
Process Validation
Root Cause Analysis
Process Improvement
Statistical Analysis
Validation Protocols
Six Sigma Methodology
New Product Development
Manufacturing Processes
Artificial Intelligence
Manufacturing Operations
Deviation Investigations
Manufacturing Engineering
Quality Management Systems
Engineering Design Process
Continuous Improvement Process
Qualification Protocols (IQ/OQ/PQ)
Corrective And Preventive Action (CAPA)

## Description

Innovation
Business Process
Document Control
Resource Planning
ISO/IEC Standards
Software Validation
Regulatory Compliance
Constructive Feedback
Artificial Intelligence
Quality Management Systems
Engineering Design Process
Software Quality (SQA/SQC)
Product Lifecycle Management
Enterprise Resource Planning, We are seeking a Software Quality Engineer with expertise in authoring NonProduct Software Validation quality records for Quality Management Systems. The ideal candidate will ensure compliance with applicable regulations, standards, and corporate governing procedures, with a focus on systems such as Training, Document Control, PLM, and ERP., * Author NonProduct Software Validation quality records in accordance with regulations, standards, and corporate procedures.

 * Act as a subject matter expert for 21 CFR Part 820, ISO standards, and 21 CFR Part 11/Annex 11.
 * Evaluate quality records for compliance and deliver constructive feedback to authors.
 * Coach coworkers on regulatory compliance and applicable governing procedures.
 * Perform approver roles including Change Initiator, Quality Representative, Business Process Owner, and Technical System Owner.
 * Manage multiple concurrent projects, ensuring all deliverables are completed and maintaining visibility into progress., Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
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