Job Description:

We are on the lookout for a dedicated individual to join our innovative team. The Software Quality Engineer will play a pivotal role in ensuring our software products uphold the highest standards of quality and performance. This position involves the development and implementation of quality assurance standard operating procedures to align with regulatory requirements. The successful candidate will be responsible for reviewing and approving test plans and cases, issuing test record documents for software verification, and developing requirement traceability metrics. They will also review and approve software documentation for regulatory submissions, facilitate design input and software release ceremonies, and ensure that software risk documentation is meticulously maintained. The role will require the establishment of metrics to gauge the quality and performance of our software, and the monitoring and analysis of user feedback and defect reports to pinpoint areas in need of enhancement. Collaboration with product teams to ensure alignment between software deliverables and business or user requirements is also a critical aspect of this role.

IT Languages:

• C++
• Python
• Java

The Software Quality Engineer will be responsible for various tasks to ensure software quality and compliance.:

Design, develop, and implement quality assurance procedures for software products;; Review and approve test plans and cases for software validation;; Issue test record documents for software verification processes;; Develop and maintain requirement traceability metrics;; Review and approve documentation required for regulatory submissions;; Facilitate software design input sessions and release ceremonies;; Review software risk documentation to ensure safety and usability;; Establish quality metrics and monitor software performance;; Analyze user feedback and defect reports for continuous improvement;; Collaborate with product teams to meet user and business requirements;; Review verification reports post-release;; Oversee Software Bill of Materials to ensure current software packages;; Own FDA 510(k) submission documents;; Participate in software architecture design and reviews

Spoken Languages:

• English

Skillset:

• Quality assurance
• Regulatory compliance
• Software testing
• Risk assessment
• Documentation review

Soft Skills:

• Effective communication
• Problem-solving
• Adaptability
• Team collaboration
• Attention to detail

Qualifications:

• Bachelor’s Degree in Computer Science, Engineering, or related field
• Moderate experience in software regulatory environments
• Strong knowledge of industry standards such as IEC 62304, IEC 60601, ISO-IEC 80001, ISO 14971, ISO 13485, and FDA regulations

Years of Experience:

5

Location:

Carlsbad, CA, United States

Job Benefits:

• Competitive salary package
• Health insurance
• Retirement savings plan
• Flexible working hours
• Professional development opportunities

Working Conditions:

Full Time

Employment Type:

Permanent Contract

Company Culture:

• We foster a collaborative and innovative environment where interdisciplinary teamwork is encouraged. Our team values independent initiative and a proactive approach to problem-solving, creating a workplace that thrives on creativity and excellence.

Opportunities For Advancement:

• Career growth within the company, Opportunities to work on cutting-edge technology, Potential leadership roles in future projects

Visa Sponsorship:

Available