Lead Software Quality Assurance Engineer

2 weeks ago


Irvine, California, United States Talent Elite Group Full time

We are seeking 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 take charge of the ongoing development and management of our Quality Management System (QMS), ensuring compliance with industry standards.

PRIMARY RESPONSIBILITIES:

QMS Development and Oversight:

Supervise the ongoing enhancement of the Quality Management System (QMS) to guarantee adherence to FDA Regulations and ISO 13485 Design Controls.

Incorporate both internal and external best practices from the medical device sector into our QMS methodologies.

Oversee the administration and upkeep of the QMS software to ensure its efficient utilization throughout the organization.

Collaboration with Development Teams:

Engage closely with software development teams to generate comprehensive Design History Files (DHF).

Produce and maintain thorough documentation, including software development plans, verification and validation strategies, requirements specifications, and design documents.

Conduct design and code evaluations to ensure quality and regulatory compliance.

Manage the Software Risk Management File (RMF), which includes the formulation of testing protocols and reports.

Ensure that comprehensive traceability matrices are upheld, linking all development and testing artifacts.

REQUIREMENTS:

Bachelor's degree in Health Sciences, Biomedical Engineering, Quality Assurance, or a related discipline.

Demonstrated experience with Quality Management Systems, particularly in relation to US FDA Quality System Regulations and ISO 13485.

Strong foundation in software development processes and documentation practices.

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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