Sr. QA Software Engineer (ISO 13485)

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Prismatik Dentalcraft, a Glidewell Dental division, seeks a senior software compliance professional for onsite Irvine duties. You will interpret regulations, guide SDLC documentation, and engage in QMS activities under FDA QSR and ISO 13485.

Required: 8+ years in medical device software, IEC 62304/14971, Agile, and web development experience. This role focuses on risk management, testing, and ensuring regulatory alignment.

Qualifications

• 8+ years in FDA QSR/ISO 13485 software engineering in medical devices.
• Experience applying IEC 62304, ISO 14971, IEC 60601 and IEC 62366.
• Experience with Agile (Scrum/Kanban) and non-embedded web development.

Responsibilities

• Provide guidance to interpret policies to assure regulatory compliance.
• Collaborate with SDLC teams to document software plans, requirements, design, and risk management.
• Participate in QMS activities in line with US FDA QSR and ISO 13485.
• Contribute to software risk management including cybersecurity.
• Stay current on regulations to support software compliance.
• Test software and assess effectiveness against standards.

Skills

Regulatory compliance

SDLC documentation

Quality Management System

Cybersecurity risk management

Agile methodologies

Web development experience

Education

Bachelor’s degree or equivalent experience

8+ years medical device software experience

Job description

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:

• Bachelor’s degree in Computer Science, Software Engineering, Informatics, 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 software engineering in the FDA QSR/ISO 13485 within 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 other than embedded software development areas, such as web development, required.
• Previous experience with cloud-based software, preferred.

Pay range: $95,000-130,000k/yr

Leveling and actual compensation may vary based on skills and experience.

This role is fully onsite at our Irvine, CA campus. Remote or hybrid arrangements are not available.