Lead Software Quality Assurance Engineer
1 week ago
We are looking for a highly skilled Senior Software Quality Assurance Engineer with a deep understanding of US FDA Quality System Regulations and ISO 13485 Design Controls. The ideal candidate will be responsible for the ongoing development and management of our Quality Management System (QMS), ensuring compliance with industry standards.
KEY RESPONSIBILITIES:
QMS Development and Oversight:
Manage the ongoing enhancement of the Quality Management System (QMS) to ensure compliance with FDA Regulations and ISO 13485 Design Controls.
Incorporate best practices from the medical device sector into our QMS procedures.
Oversee the administration and upkeep of QMS software to guarantee its effective application throughout the organization.
Collaboration with Development Teams:
Partner with software development teams to produce thorough Design History Files (DHF).
Create and sustain comprehensive documentation, including software development plans, verification and validation plans, requirements specifications, and design documents.
Conduct design and code evaluations to ensure quality and regulatory compliance.
Manage the Software Risk Management File (RMF), including the formulation of testing protocols and reports.
Ensure that comprehensive traceability matrices are maintained, linking all development and testing artifacts.
Qualifications:
Bachelor's degree in Health Sciences, Biomedical Engineering, Quality Assurance, or a related discipline.
Demonstrated experience with Quality Management Systems, particularly with US FDA Quality System Regulations and ISO 13485.
Strong foundation in software development processes and documentation.
Proficient in utilizing QMS software and tools.
Exceptional communication and teamwork abilities.
Meticulous attention to detail and commitment to regulatory standards.
Strong analytical and organizational capabilities.
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