Quality Engineer

The Senior Quality Engineer provides advanced Process and Quality Engineering support to manufacturing and product development teams, ensuring delivery of the highest-quality products to customers. This role partners closely with Manufacturing Engineering, Production, and R&D to support both sustaining manufacturing operations and new product development.

The Senior Quality Engineer serves as a technical leader, driving robust process controls, leading complex investigations, mentoring team members, and advancing continuous improvement initiatives within a regulated medical device environment.

This role follows an onsite work model and is based in Orange County, CA.

• Partner with Manufacturing Engineering and Production teams to provide day-to-day quality support for manufacturing operations
• Design, implement, and maintain effective process control systems to meet internal, customer, and regulatory requirements
• Lead complex quality investigations using structured problem-solving methodologies (e.g., DMAIC, root cause analysis)
• Analyze manufacturing and process data (scrap, nonconformances, complaints) to drive product and process improvements
• Proactively identify and implement best-in-class Quality Engineering practices
• Lead and participate in CAPA investigations and corrective action implementation
• Support sustaining product quality as well as New Product Introduction (NPI) activities
• Promote and strengthen a culture of continuous improvement across manufacturing operations
• Provide technical guidance, coaching, and mentorship to technicians and junior engineers
• Collaborate cross-functionally to resolve highly complex quality and process issues
• Apply risk-based thinking to quality decisions and process improvements

• Bachelor’s degree in Engineering or a related STEM discipline
• Minimum of 5+ years of experience in quality, manufacturing, or operations within a regulated medical device environment
• Strong working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and applicable global regulatory requirements
• Demonstrated experience leading quality investigations and CAPA activities
• Proficiency with quality tools and data analysis methods

• Bachelor’s degree in Electrical Engineering or experience with electronic components and PCBAs
• Experience supporting New Product Introduction (NPI) programs
• Demonstrated ability to lead resolution of highly complex quality and process issues
• Strong collaboration and influencing skills across cross-functional teams
• Hands-on approach to nonconformance investigation and troubleshooting
• Experience mentoring or leading technicians or junior engineers