Software Quality Engineer

Overview

Remote
On Site
Hybrid
$44.1 - $63 hr
Full Time
Contract - Independent
Contract - W2

Skills

Software Design
Data Processing
Verification And Validation
System Requirements
Cyber Security
Collaboration
Product Development
Design Controls
Training
Software Quality Assurance
Regulatory Compliance
Curriculum
Quality Assurance
Medical Devices
Software Development
Quality Management
Risk Management
Agile
Software Development Methodology
AS/400 Control Language
Common Lisp

Job Details

Title: Software Quality Engineer

Location: Remote (Regional)
Employment Type: Contract

Compensation
Pay Range:$44.10-$63.00/hrs

Description
* Implement software design control and quality systems ensuring compliance with regulations and industry best practices.
* Lead quality assurance and regulatory activities throughout the software development lifecycle for product development and automated data processing systems.
* Ensure software development processes comply with applicable standards and regulations, supporting cybersecurity development processes.
* Interface with cross-functional teams and external parties on issues related to product development, launched products, and quality management systems.
* Lead design control and software development initiatives to develop appropriate design history file documents for medical devices and cybersecurity.
* Plan verification and validation of system requirements and user needs for integrated systems.
* Support risk management activities for complex systems in compliance with international standards.

Key Responsibilities
* Lead quality assurance and regulatory activities for new product development.
* Ensure compliance with standards and regulations, including cybersecurity requirements.
* Collaborate with cross-functional teams on product development and quality management.
* Develop and deliver design control training across various functions.
* Review and provide feedback on requirements, specifications, and validation protocols.
* Establish and maintain software quality assurance processes and controls.
* Drive and improve quality management system regulation compliance.

Qualifications
* BS degree in engineering, scientific, computer system, or quality management curriculum or equivalent experience.
* 8-10 years of work experience in software quality engineering within a regulated environment.
* Experience with hazard analysis and failure mode and effect analysis.
* Experience with medical device software development.
* Experience with risk-based approach to validate commercial off-the-shelf software and tools.
* Working knowledge of quality system regulations and standards.

Core Technologies
* Software Development Tools | Quality Management Systems | Risk Management Tools | Validation Practices | Agile SDLC Tools

Contact Information
Christopher Lopez,

Benefits
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EEO Statement
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