Software Quality Assurance Consultant

ACL Digital; United States; Remote; USD 90,000 - 105,000; Full time

Job summary

ACL Digital is looking for a Software Quality Assurance Consultant to support a complex project. This remote position requires oversight in biomedical software quality, strong communication skills, and a rich background in FDA regulations. The ideal candidate will have 10-15 years of relevant experience, contribute to the entire software lifecycle, and work collaboratively within a team to enhance product integrity and compliance.

Qualifications

• 10-15 years of experience in quality assurance.
• Background in medical devices or GMP strongly preferred.
• Ability to work in fast-paced multi-disciplinary teams.

Responsibilities

• Provides guidance and quality oversight of the development process.
• Participates in various phases of the Software Development Life Cycle.
• Leads process improvements and executes corrective actions.

Skills

Knowledge in an FDA-regulated environment

Software development life cycle

Risk management

Configuration management

Communication skills

Documentation skills

Multi-disciplinary teamwork

Education

4 year college degree

Job description

This range is provided by ACL Digital. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $65.00/hr

Direct message the job poster from ACL Digital

Job Title: Software Quality Assurance Consultant

Location: Remote

Duration: 15+ Months

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.

1. Provides guidance and quality oversight of the development, testing strategy, validation, and documentation of biomedical software, ensuring compliance with established procedures and regulatory requirements.

2. 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.

3. 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.

4. Identifies and executes process improvements to strengthen internal procedures and processes and improve quality and efficiency.

5. Leads or participates on project teams, task forces, and other complex cross-functional teams.

6. Serves as a subject matter expert in Quality Assurance for software and hardware validation.

7. 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.

8. Reviews and approve internal procedures, ensuring regulatory requirements are met, and focusing on procedure clarity and efficient processes.

9. Monitors and reports on changing technology, practices, standards, and regulatory and compliance requirements within the biomedical industry.

Qualifications:

Education: 4 year college degree. Experience: 10 - 15 years. Other Skills:

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

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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