Senior Quality Engineer

Senior Quality Engineer | Medical-Devices | Full Time | Los Angeles, CA

I’m supporting an early-stage medical technology company developing a highly advanced, software-led surgical platform.

This is an opportunity to join a small, accomplished team working on technology with the potential to improve how complex procedures are performed and ultimately deliver better outcomes for patients.

Quality is still a lean function, so this position offers considerably more ownership than a conventional Senior Quality Engineer role.

You’ll work closely with the company’s quality leadership while independently supporting engineering teams through product development, verification, validation and future manufacturing readiness.

The number-one requirement is deep, practical experience with medical-device design controls.

We’re particularly interested in candidates who have personally supported or owned:

• Design inputs and outputs
• Design reviews and requirements traceability
• Design History Files
• Risk-management activities
• Verification and validation documentation
• Design changes and configuration control
• Software lifecycle and design-assurance activities
• Cross-functional collaboration with software and product-development teams

Because the product is heavily software-led, candidates must also have meaningful experience with software-containing medical devices, including knowledge of IEC 62304 and software V&V.

The wider system incorporates hardware and firmware, so experience working across the interfaces between software, firmware and physical products would be valuable.

Candidates must come directly from the medical-device industry - ideally surgical devices or another complex, safety-critical medical platform. Previous robotics experience is not required.

Additional exposure to manufacturing, supplier quality, design transfer, CAPA or supply-chain environments would be beneficial, but these are secondary to strong design-control and software-quality experience.

This opportunity will suit someone who:

• Can operate independently within a lean quality organization
• Is comfortable creating structure rather than inheriting everything fully established
• Can constructively challenge engineering teams
• Enjoys combining detailed quality work with wider product-development responsibility
• Wants their work to have a visible influence on both the product and the company

#Medical Devices #Quality Engineering #Design Controls #Software Quality #IEC
62304 #Design Assurance #Los Angeles Jobs