Software Quality Assurance Consultant

cGxPServe Inc.; Boston (MA); Remote; USD 110,000 - 130,000; Full time

Job summary

A leading company in Research Services is seeking a Software Quality Assurance Consultant for a fully remote position. This role involves supporting and ensuring compliance in the development of biomedical software, leading quality assurance efforts, and collaborating with multi-disciplinary teams. Candidates should have extensive experience in FDA-regulated environments and possess strong communication and documentation skills.

Qualifications

• 10 - 15 years of experience required.
• Knowledge in an FDA-regulated environment preferred.
• Background in medical devices or GMP strongly preferred.

Responsibilities

• Provide guidance and oversight on software development and testing.
• Ensure compliance with established regulatory requirements.
• Identify and investigate software defects.

Skills

Excellent understanding of software development life cycle

Risk management

Configuration management

Exceptional communication skills

Documentation skills

Ability to work in multi-disciplinary teams

Education

4-year college degree

Job description

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Job Description

Supports development, testing, validation and documentation of biomedical software by participating as an integral team member in various phases of the System Development Life Cycle (SDLC), providing guidance on established Red Cross procedures and regulatory requirements. Develops quality plans and recommends updates to existing procedures as required improving and/or strengthening the SDLC.

Job Description

Supports development, testing, validation and documentation of biomedical software by participating as an integral team member in various phases of the System Development Life Cycle (SDLC), providing guidance on established Red Cross procedures and regulatory requirements. Develops quality plans and recommends updates to existing procedures as required improving and/or strengthening the SDLC.

Responsibilities

• This Software Quality Assurance will be supporting the internal team on this highly complex and mission critical project. This is a fully remote position. East Coast hours.
• Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements.
• Participates as an integral team member in various phases of the Software Development Life Cycle (SDLC), providing timely and meaningful feedback for project documentation including software requirements, design, test plans, test cases, and summary reports, and ensuring compliant quality product releases. Anticipates issues and develops consensus-based solutions by partnering with project teams.
• Effectively collaborates as an internal quality consultant to advise or influence business or technical partners, providing guidance on quality and regulatory requirements, advising IT staff and management on quality and regulatory issues, and recommending solutions and best practices.
• Identifies and executes process improvements to strengthen internal procedures and processes and improve quality and efficiency.
• Leads or participates on project teams, task forces, and other complex cross-functional teams.
• Serves as a subject matter expert in Quality Assurance for software and hardware validation.
• Identifies and investigates software defects and other problems. Serves as an active participant in the development of corrective and preventive action plans, ensuring regulatory requirements are met.
• Reviews and approve internal procedures, ensuring regulatory requirements are met, and focusing on procedure clarity and efficient processes.
• Monitors and reports on changing technology, practices, standards, and regulatory and compliance requirements within the biomedical industry.
  
  

Requirements:

• 4-year college degree. Experience: 10 - 15 years.
• Knowledge and/or experience in an FDA-regulated environment required, background in medical devices or GMP is strongly preferred.
• Excellent understanding of software development life cycle, risk. management, and configuration management.
• Exceptional communication and documentation skills.
• Ability to work as part of a multi-disciplinary teams in a fast-paced environment.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Research Services

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Boston, MA $110,000.00-$130,000.00 2 weeks ago

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