Desired start date: April 3rd 2023

Location: San Carlos, CA

We believe the future of the operating room lies in the hands of the empowered surgeon. They are bolstered with complete control, renewed confidence, and technology adaptable to any situation.

Our Maestro System delivers this empowerment, resulting in improved operating room efficiency and surgical care for patients - We are using tomorrow's technology to change surgery today.

Our blended French-American team is passionate about building this future. Together we are pushing the boundaries in a fast-paced yet focused and deliberate environment. We challenge ourselves often and celebrate our achievements. We believe that communication and planning are as important as execution.

🎉 The Role

The Quality Engineer is responsible for the application of quality engineering principles to supplier engineering, manufacturing processes, sustaining engineering, and new product introduction. Responsibilities include supporting incoming inspection, NCRs, deviations, test method validation, process validation, equipment qualifications and statistical techniques.  A working knowledge of production processes necessary to build highly complex capital equipment is key in this role.  The Quality Engineer represents the Quality Assurance function with suppliers, manufacturing and R&D and will ensure that appropriate process controls are in place to ensure product conformity. A strong statistical & GD&T background is a plus. The ability to make data driven decisions is critical to this role.

Responsibilities

• Acts as both an onsite Quality Engineer for onsite manufacturing and a supplier Quality Engineer
• Support design, development and manufacture of products.
• Assure finished products conform to regulations and applicable standards satisfying the QSR 21 CFR 820, ISO 13485, ISO 14971, and other relevant requirements.
• Support initiatives of higher-level objectives such as QMS updates to meet international standards and regulations (e.g. EU MDR).
• Work with Manufacturing & Operations to drive continuous improvement through business and quality objectives and resolve issues that could impact product quality or regulatory compliance.
• Provide Quality Engineering support for production; addresses non-conformances through the NCR/CAPA system - driving escalation when risk level warrants it - and participates in complaint investigations (if needed).
• Provide support for internal audits, third party audits, FDA inspections, and Notified Body audits.
• Interface with all internal departments to proactively identify potential issues and develop solutions to minimize or prevent adverse effects on products.
• Soft skills – a team player, ability to pivot quickly to address issues critical to business success, ability to articulate a complex issue to a actionable item(s) and prioritize work effectively.
• Perform other duties as assigned*.*

🧭 Qualifications, Skills & Attributes