PRISMATIK DENTALCRAFT, INC.
Sr. Quality Assurance Software Engineer
PRISMATIK DENTALCRAFT, INC., Irvine, California, United States, 92713
Sr. Quality Assurance Software Engineer (ISO 13485)
Sr. Quality Assurance Software Engineer (ISO 13485)
Get AI-powered advice on this job and more exclusive features. Prismatik Dentalcraft is a division of Glidewell Dental Essential Functions: Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Partners with software development teams in Software Development Lifecycle (SDLC) documentation including software development plans, software verification and validation, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices. Participates in Quality Management System (QMS) activities in compliance with US FDA Quality System Regulations and ISO 13485. Participates in software risk management activities including cybersecurity risk by collaborating and providing feedback to software development teams. Remains current on existing and new regulations to support compliance of existing software. Utilizes knowledge and expertise guide development team in seeking solutions and alternatives to meet regulations. Conducts testing and assesses the effectiveness and accuracy of software against existing operating standards or performance guidelines. Minimum Qualifications: Bachelors degree in Engineering, Biomedical, or related technical field; or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved. Minimum eight (8) years of experience in quality engineering in the FDA QSR/ISO 13485 medical device industry. Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment) and IEC 62366 Usability Engineering, required. Experience with Agile software development methodologies like Scrum and Kanban, required. Experience with embedded software development areas, such as web development, required. Previous experience with cloud-based software, preferred. Pay range: $95,833-$130,000/yr Exact compensation may vary based on skills and experience. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Engineering and Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at PRISMATIK DENTALCRAFT, INC. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Assurance Engineer jobs in
Irvine, CA . Quality Assurance/Supplier Quality Engineering/Quality Control (QA/SQE/QC) Engineer
Irvine, CA $150,000 - $200,000 7 hours ago Software Development Engineer in Test - 2025 (US)
Irvine, CA $105,000.00 - $185,000.00 9 hours ago Irvine, CA $100,000.00 - $120,000.00 1 day ago Irvine, CA $110,000.00 - $130,000.00 3 days ago Rancho Santa Margarita, CA $100,000.00 - $120,000.00 2 weeks ago Irvine, CA $100,000.00 - $150,000.00 1 day ago Rancho Santa Margarita, CA $115,000.00 - $125,000.00 2 weeks ago Software Quality Assurance Engineer (QA / QC) In-Person in Aliso Viejo
Quality Assurance & Quality Control Engineer II
Software Development Engineer in Test 2025 (US)
Irvine, CA $105,000.00 - $185,000.00 1 week ago 3.94 Software Quality Assurance Engineer
Irvine, CA $100,000.00 - $120,000.00 3 months ago Irvine, CA $100,000.00 - $150,000.00 3 months ago Software Engineer II/ Quality Automation
Irvine, CA $100,000 - $120,000 2 hours ago Irvine, CA $100,000 - $120,000 3 months ago Santa Ana, CA $110,000 - $130,000 5 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Sr. Quality Assurance Software Engineer (ISO 13485)
Get AI-powered advice on this job and more exclusive features. Prismatik Dentalcraft is a division of Glidewell Dental Essential Functions: Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Partners with software development teams in Software Development Lifecycle (SDLC) documentation including software development plans, software verification and validation, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices. Participates in Quality Management System (QMS) activities in compliance with US FDA Quality System Regulations and ISO 13485. Participates in software risk management activities including cybersecurity risk by collaborating and providing feedback to software development teams. Remains current on existing and new regulations to support compliance of existing software. Utilizes knowledge and expertise guide development team in seeking solutions and alternatives to meet regulations. Conducts testing and assesses the effectiveness and accuracy of software against existing operating standards or performance guidelines. Minimum Qualifications: Bachelors degree in Engineering, Biomedical, or related technical field; or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved. Minimum eight (8) years of experience in quality engineering in the FDA QSR/ISO 13485 medical device industry. Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), IEC 60601 (Medical Electric Equipment) and IEC 62366 Usability Engineering, required. Experience with Agile software development methodologies like Scrum and Kanban, required. Experience with embedded software development areas, such as web development, required. Previous experience with cloud-based software, preferred. Pay range: $95,833-$130,000/yr Exact compensation may vary based on skills and experience. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Engineering and Quality Assurance Industries
Medical Equipment Manufacturing Referrals increase your chances of interviewing at PRISMATIK DENTALCRAFT, INC. by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Assurance Engineer jobs in
Irvine, CA . Quality Assurance/Supplier Quality Engineering/Quality Control (QA/SQE/QC) Engineer
Irvine, CA $150,000 - $200,000 7 hours ago Software Development Engineer in Test - 2025 (US)
Irvine, CA $105,000.00 - $185,000.00 9 hours ago Irvine, CA $100,000.00 - $120,000.00 1 day ago Irvine, CA $110,000.00 - $130,000.00 3 days ago Rancho Santa Margarita, CA $100,000.00 - $120,000.00 2 weeks ago Irvine, CA $100,000.00 - $150,000.00 1 day ago Rancho Santa Margarita, CA $115,000.00 - $125,000.00 2 weeks ago Software Quality Assurance Engineer (QA / QC) In-Person in Aliso Viejo
Quality Assurance & Quality Control Engineer II
Software Development Engineer in Test 2025 (US)
Irvine, CA $105,000.00 - $185,000.00 1 week ago 3.94 Software Quality Assurance Engineer
Irvine, CA $100,000.00 - $120,000.00 3 months ago Irvine, CA $100,000.00 - $150,000.00 3 months ago Software Engineer II/ Quality Automation
Irvine, CA $100,000 - $120,000 2 hours ago Irvine, CA $100,000 - $120,000 3 months ago Santa Ana, CA $110,000 - $130,000 5 days ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr