Senior QA Engineer - Medical Device Compliance & SDLC

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, 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.