Senior SaMD Quality Engineer — Validation & Compliance

International Executive Service Corps; Monrovia (CA); On-site; USD 115,000 - 150,000; Full time

Job summary

STAAR Surgical is seeking a quality engineering professional to coordinate activities for SaMD, software platforms, and manufacturing software, ensuring adherence to FDA QSR and ISO 13485. You will guide risk analyses, design controls, and validation strategy across the software lifecycle.

The role requires experience in medical device software change management, strong communication, and leadership within cross-functional teams.

Qualifications

• Bachelor's degree in Engineering or sciences required.
• Advanced degree preferred.
• CQE or equivalent preferred.

Responsibilities

• Coordinate quality engineering activities supporting SaMD, Quality System software, and Manufacturing software platforms.
• Provide technical expertise through the software lifecycle with focus on SaMD (design control, risk analyses, V&V strategy).
• Develop strategy with cross-functional teams to support compliant release of SaMD and other software.
• Lead design/control and validation policy development; support quality disciplines and decisions.
• Guide risk documentation processes.
• Lead investigations on software nonconformances and CAPA; perform risk analyses and root cause analysis.
• Participate in preparation of nonconformance investigations and corrective actions.
• Guide design processes and site engineering to identify critical parameters for quality improvements.
• Participate on Design Control New Product Development teams; review deliverables.
• Other duties as assigned.

Skills

Technical writing

English proficiency

Project management

Communication skills

Presentation skills

Education

Bachelor's degree in engineering or sciences

Advanced degree preferred

Certified Quality Engineer (CQE) or equivalent preferred

Job description

STAAR Surgical is seeking a quality engineering professional to coordinate activities for SaMD, software platforms, and manufacturing software, ensuring adherence to FDA QSR and ISO 13485. You will guide risk analyses, design controls, and validation strategy across the software lifecycle.

The role requires experience in medical device software change management, strong communication, and leadership within cross-functional teams.