Desired start date: October 15th 2022
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.
We are looking for humble, diligent, and audacious individuals who share our vision and want to change the world.
🎉 The Role
The Senior 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 line down situations, NCRs, deviations, test method validation, process validation, equipment qualifications and statistical techniques. A working knowledge of risk management and 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.
- Create and continuously update quality processes that are efficient, compliant, and scalable to support a growing organization.
- Analyze issues to collaborate on root causes and work to prevent reoccurrence. This responsibility includes interfacing with suppliers to resolve issues.
- Acts as both an onsite Quality Engineer for onsite manufacturing and a supplier Quality Engineer for their business unit.
- Assess potential new suppliers for technical, quality, QMS maturity, and manufacturing capabilities.
- Participates or leads supplier audits to evaluate technical abilities, quality capabilities, and QMS maturity.
- Provides technical support for the introduction of components from a new supplier.
- Drive risk-based evaluation of data and implementation of processes using a risked based approach and sound statistical techniques.
- Assure finished products conform to regulations and applicable standards satisfying the QSR, ISO, and other relevant requirements.
- Key participant in monthly QMS reviews and management review meetings; compile and analyze quality metrics and data with the objective of establishing goals and identifying trends. (NCR/TD/Rework)
- Support initiatives of higher-level objectives such as QMS updates to meet international standards and regulations (e.g. EU MDR).
- Work with Manufacturing Engineering 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).
- Work with Manufacturing and Service organizations to resolve non-conformances and identify opportunities for improvement.