Software Quality Assurance Consultant - REMOTE EST OR CST-W2

Davita Inc.; Cary (NC); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Software Quality Assurance Consultant to oversee biomedical software projects in a remote capacity. Ideal candidates will possess extensive experience in quality assurance within FDA-regulated environments and have strong proficiency in GxP methodologies. This role involves providing expertise throughout the software development life cycle, ensuring compliance, and enhancing software processes to meet high industry standards.

Qualifications

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

Responsibilities

• Oversee development, testing, validation, documentation of biomedical software.
• Act as a quality consultant on biomedical IT projects.
• Review and approve procedures for regulatory compliance.

Skills

Quality Assurance

Risk Management

Analytical Skills

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 jour client, Remote, EST or CST
to report from their 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 location clearly listed on resume
**While 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 a complete list of responsibilities or requirements. Full client job description will be provided upon formal submission to client

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: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

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

Visit https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.