Job Description
Job Description:
Join a leading biomedical software development project and provide Quality Assurance oversight throughout the Software Development Life Cycle (SDLC), ensuring compliance with regulatory standards (FDA/GMP). You'll act as a QA subject matter expert on cross-functional teams.
Responsibilities:
- Provide QA oversight and regulatory compliance across software development and validation phases.
- Review project documentation: requirements, designs, test plans/cases, and summary reports.
- Identify and resolve software defects and develop CAPAs.
- Act as internal QA advisor across teams.
- Lead/participate in cross-functional process improvement efforts.
- Monitor evolving biomedical regulatory standards.
- Approve internal procedures to ensure regulatory compliance.
Requirements:
- Bachelor's degree (required).
- 10–15 years of QA experience, ideally in a medical device or FDA-regulated environment.
- In-depth knowledge of SDLC, risk management, and configuration management.
- Excellent written and verbal communication skills.
- Able to collaborate effectively in cross-disciplinary teams in a fast-paced setting.