Software Quality Assurance Consultant - REMOTE EST OR CST-W2

Yoh Services LLC; Cary (NC); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the humanitarian sector is seeking a Software Quality Assurance Consultant for a remote contract opportunity. With a focus on biomedical software, the role involves overseeing compliance, providing technical expertise in the software development life cycle, and ensuring regulatory standards are met. The ideal candidate will have extensive experience in quality assurance within FDA-regulated environments, along with strong analytical and communication skills.

Qualifications

• 10–15 years' experience in quality assurance or software validation.
• Experience in FDA-regulated environments is preferred.
• Strong knowledge of GxP and risk management methodologies.

Responsibilities

• Oversee development, testing, validation, and documentation of biomedical software.
• Act as a quality and regulatory consultant throughout the SDLC.
• Review and approve procedures for regulatory compliance.

Skills

Analytical skills

Attention to detail

Communication

Education

Bachelor’s degree in biomedical or software engineering

Job description

Software Quality Assurance Consultant - REMOTE EST OR CST-W2

Category: Quality

Employment Type: Contract

Reference: BH-385771

Yoh has an immediate, 12+ month, contract opportunity for a Software Quality Assurance Consultant - Biomedical Software within the non-profit, humanitarian industry, to serve our client. This role is remote, EST or CST, reporting from the office based in Raleigh, NC.

• $65-70/hr max rate, W2 ONLY
• 10–15 years in quality assurance or software validation, preferably in an FDA-regulated environment.
• Experience in R&D or product development in the biomedical or life sciences sector.

All applicants should have their location clearly listed on their resume. While the position is remote, only applicants in EST or CST locations will be considered.

What You Will Be Doing

• Oversee development, testing, validation, and documentation of biomedical software to ensure regulatory compliance.
• Provide technical expertise throughout the Software Development Life Cycle (SDLC), including requirements, design, testing, and release.
• Act as a quality and regulatory consultant on biomedical IT projects, including risk management and corrective actions.
• Investigate process deviations and recommend improvements.
• Serve as QA subject matter expert for hardware/software projects.
• Review and approve procedures, protocols, and design documents for regulatory compliance.

This is not an exhaustive list of responsibilities or requirements. The full client job description will be provided upon formal submission.

Who You Are

• Bachelor’s degree (biomedical or software engineering preferred).
• 10–15 years’ experience, including FDA-regulated environments.
• Strong knowledge of GxP and risk management methodologies.
• Excellent written communication and documentation skills.
• Strong analytical skills and attention to detail.
• Effective in multidisciplinary team settings.

If this sounds like you, apply now!

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Estimated Min Rate: $65.00

Estimated Max Rate: $70.00

Note: Pay ranges are estimations. Actual pay depends on experience, expertise, and qualifications. All qualified applicants are encouraged to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Visit https://www.yoh.com/applicants-with-disabilities for accommodation requests during the application process.

For California applicants, consideration is in accordance with local laws regarding criminal records.

Posted on 05-30-2025