Quality Engineer: Process Improvement & Risk Lead

Real; Santa Clara (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Real is seeking a proactive and technically strong Quality Engineer to support a fast-paced, highly collaborative product development environment. This role spans quality and manufacturing activities, contributing to development, process optimization, and commercialization efforts.

The ideal candidate will work independently with cross-functional teams, own design transfer and process qualification, drive improvements, and help resolve nonconformances throughout the lifecycle.

Qualifications

• Strong understanding of Quality Management Systems (QMS) within a regulated environment.
• Demonstrated ability to quickly learn complex products, subassemblies, and manufacturing processes.
• Proven technical capability in quality engineering, manufacturing support, or a related field.
• Experience supporting process qualification, FMEAs, and nonconformance activities.
• Ability to work independently with minimal oversight while managing multiple priorities.
• Strong collaboration and problem-solving skills, with the ability to engage cross-functional teams.

Responsibilities

• Support integrated development and engineering (IDE) builds, repair activities, and clinical build initiatives.
• Contribute to De Novo program support and regulatory-related quality efforts.
• Participate in design transfer activities, including execution and documentation.
• Manage and support nonconformance investigations and resolution activities.
• Lead and contribute to Process FMEA development and updates.
• Develop, review, and maintain manufacturing and quality documentation.
• Drive process improvements and continuous improvement initiatives.
• Support process qualification activities, including protocol development and report generation.
• Participate in design reviews, residual risk assessments, and lifecycle documentation updates.
• Collaborate cross-functionally to identify issues, bring together key stakeholders, and help drive effective solutions.

Skills

Quality Eng

QMS

Regulatory

FMEA

Nonconformance

Process Improvement

Documentation

Cross-functional

Job description

Real is seeking a proactive and technically strong Quality Engineer to support a fast-paced, highly collaborative product development environment. This role spans quality and manufacturing activities, contributing to development, process optimization, and commercialization efforts.

The ideal candidate will work independently with cross-functional teams, own design transfer and process qualification, drive improvements, and help resolve nonconformances throughout the lifecycle.