Quality Assurance Engineer
7 days ago
Top 3 Skills:
- Standalone Software as a Medical Device (SaMD)– 3-5 years recent
- Quality management systems (QMS)
- Should be a Quality Engineer/Design Assurance Engineer in recent 3-5 years no managerial experience required.
Red Flag in Resume:
Not Required:
- Experience in Computer System Validation (CSV)
- Experience in Test Engineering (V&V)
- Regulatory Affairs experience (although may be a plus)
Top 3 Daily Responsibilities: (3+ bullets of the main responsibilities on the assignment)
- Participate in ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, as well as SDLC processes and tool initiatives, through the integration of internal and external/medical device industry best practices.
- Support software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports and traceability matrices.
- Support integration of ISO 14971 risk management and IEC 62366 usability engineering activities with SDLC processes.
- Guide software development teams in design controls and risk management activities.
- Foster organizational compliance to the quality system including ongoing training and education on software QMS and SDLC framework. Provide CAPA, complaints, audit and overall QMS support in regards to software.
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Quality Assurance Engineer
5 days ago
san bruno, United States SRM Digital LLC Full timeTop 3 Skills:Standalone Software as a Medical Device (SaMD)– 3-5 years recentQuality management systems (QMS)Should be a Quality Engineer/Design Assurance Engineer in recent 3-5 years no managerial experience required.Red Flag in Resume:Not Required:Experience in Computer System Validation (CSV)Experience in Test Engineering (V&V)Regulatory Affairs...
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Quality Assurance Engineer
1 week ago
San Bruno, United States SRM Digital LLC Full timeTop 3 Skills:Standalone Software as a Medical Device (SaMD)– 3-5 years recentQuality management systems (QMS)Should be a Quality Engineer/Design Assurance Engineer in recent 3-5 years no managerial experience required.Red Flag in Resume:Not Required:Experience in Computer System Validation (CSV)Experience in Test Engineering (V&V)Regulatory Affairs...
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Software Quality Assurance Engineer
1 week ago
San Bruno, California, United States Iconma LLC Full timeJob Summary:As a Software Quality Assurance Engineer at Iconma LLC, you will play a crucial role in ensuring the highest quality standards are met in software development. You will work closely with software development teams to implement and maintain a Software Quality Management System (QMS) that conforms to US FDA Quality System Regulations and ISO 13485...
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San Bruno, California, United States US Tech Solutions Full timeJob DescriptionDuration: 5+ months contractJob Overview:US Tech Solutions is seeking a highly skilled Software Quality Assurance Engineer to join our team. As a Quality Assurance Champion, you will be responsible for ensuring adherence to high standards and corporate requirements throughout the software development lifecycle.Key Responsibilities:Act as a...
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Senior Quality Assurance Engineer
2 weeks ago
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San Jose, California, United States Tik Tok Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Engineer to join our e-commerce team at TikTok. As a Quality Assurance Engineer, you will be responsible for ensuring the stability, security, and intuitiveness of our e-commerce ecosystem.Key ResponsibilitiesParticipate in Product Requirements Document (PRD) and architectural design...
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1 month ago
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Software Quality Assurance Engineer
2 weeks ago
San Francisco, California, United States ShiftCode Analytics Full time{"title": "Software Quality Assurance Engineer", "description": "Job SummaryWe are seeking a highly skilled Software Quality Assurance Engineer to join our team at ShiftCode Analytics. As a Software Quality Assurance Engineer, you will play a critical role in ensuring the quality and reliability of our software products.Key Responsibilities:Develop and...
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SaMD/Medical Devices Software Quality Engineer
2 months ago
San Bruno, United States US Tech Solutions Full timeDuration: 5+ months contract Job Description: The client is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. The purpose is to bring the promise of precision health to everyone, every day. The client is focused on generating and activating data from a variety of sources, including clinical,...
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Staff Quality Assurance Engineer
1 week ago
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Software Quality Assurance Engineer
2 weeks ago
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Software Quality Assurance Engineer
4 weeks ago
San Jose, California, United States CISCO Systems Full timeJob Title: Software Quality Assurance EngineerCisco Systems is seeking a highly skilled Software Quality Assurance Engineer to join our team. As a Software Quality Assurance Engineer, you will be responsible for ensuring the quality and reliability of our software products.Responsibilities:Participate in the development and execution of test plans and test...