Note: The job is a remote job and is open to candidates in USA. Staftonic LLC is seeking a Software Quality Assurance Consultant for a long-term project. The role involves ensuring compliance with design controls and regulatory standards in the medical device industry, as well as collaborating with various engineering teams throughout the software development lifecycle.
Responsibilities
- Review Design History Files (DHF), software requirements, and design documentation for acquired medical device products
- Ensure compliance with Design Controls, FDA Quality System Regulations (21 CFR Part 820), and internal quality processes
- Perform software quality reviews to ensure compliance with applicable regulatory standards
- Support software design assurance activities throughout product integration and new product development
- Collaborate with software engineering, Systems Engineering, Quality, Regulatory Affairs, and Risk Management teams
- Review software verification and validation (V&V) documentation and ensure requirements traceability
- Conduct software gap assessments and support remediation activities
- Participate in design reviews, quality reviews, and documentation approvals
- Support risk management activities and software lifecycle compliance
Skills
- Bachelor's degree in Engineering, Computer Science, biomedical engineering, Software Engineering, or a related discipline
- 10+ years of Software Quality, design assurance, or Software Design Quality experience within the Medical Device industry
- Strong knowledge of Medical Device Design Controls and Design History Files (DHF)
- Hands-on experience with Software Verification & Validation (V&V)
- Experience supporting Software as a Medical Device (SaMD) or embedded medical device software
- Strong knowledge of: IEC 62304, ISO 14971, IEC 62366, IEC 60601, ISO 13485, FDA 21 CFR Part 820
- Experience with risk management, CAPA, traceability, and software quality documentation
- Excellent communication and cross-functional collaboration skills
- Experience with Model-Based Systems Engineering (MBSE)
- Experience supporting medical device mergers & acquisitions (M&A) or product integration projects
- Experience with Design Transfer, Software Remediation, and Quality System Integration
- Familiarity with tools such as Jama, Windchill, Polarion, Azure DevOps, DOORS, Greenlight Guru, or similar ALM/PLM platforms
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