Software Quality Engineer II

Duties & Responsibilities

• Partner with software development and cross-functional teams to ensure quality is integrated throughout the software development lifecycle.
• Review and approve software development deliverables including requirements, architecture, risk documentation, test protocols, traceability, and validation records.
• Support design control activities in compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and other applicable global requirements.
• Participate in design reviews, phase gate reviews, and change control activities for software-based products and systems.
• Review software verification and validation activities including unit, integration, system, cybersecurity, and user acceptance testing.
• Support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification.
• Evaluate software defects, nonconformances, and quality events to determine product impact and required actions.
• Participate in CAPA, complaint investigations, post-market surveillance, and field issue assessments involving software-related products.
• Support internal audits, external audits, and regulatory inspections by preparing documentation and providing subject matter expertise.
• Drive continuous improvement initiatives to strengthen software quality systems, processes, and compliance effectiveness.
• Aid in the creation, review, and maintenance of Design History Files (DHF), Device Master Records (DMR), and quality records.
• Mentor junior team members and provide guidance on software quality processes and best practices as needed.

Minimum Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.
• Minimum 3 years of experience in Quality Engineering, Quality Assurance, or Software Quality within a regulated industry.
• Working knowledge of software development lifecycle (SDLC), Agile and/or waterfall development methodologies.
• Experience supporting software verification and validation activities.
• Knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
• Experience with change control, nonconformance, CAPA, and complaint handling processes.
• Strong analytical, problem-solving, and risk assessment skills.
• Strong written and verbal communication skills with the ability to work cross-functionally.
• Proficiency with Microsoft Office applications and quality documentation systems.

Preferred Qualifications

• Experience supporting Software as a Medical Device (SaMD), embedded software, connected devices, or cybersecurity-focused products.
• Experience with automated test tools, defect tracking systems, or application lifecycle management systems.
• Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent certification.
• Experience in the medical device industry strongly preferred.
• Master’s degree in a related technical discipline.