Software Quality Engineer
Posted 1 day ago by 1751355804
Negotiable
Outside
Remote
USA
Summary: The Software Quality Engineer role involves implementing software design control and quality systems to ensure compliance with regulations and industry best practices. The position requires leading quality assurance and regulatory activities throughout the software development lifecycle, particularly for medical devices and cybersecurity. The engineer will collaborate with cross-functional teams and external parties to address product development and quality management issues. This is a contract position with a focus on maintaining high standards in software quality assurance processes.
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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: IT
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,
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