Desired start date: September 2024

Location: Paris, France

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 Technician at our medical device company plays a crucial role in ensuring the highest standards of product quality and compliance. This position is responsible for a variety of critical quality control activities, including incoming inspection of materials, management of Non-Conforming Material Reports (NCMRs), handling of deviations, and overseeing calibration activities. Additionally, the Quality Technician will provide essential support for manufacturing-related quality issues, collaborating closely with production teams to identify, analyze, and resolve problems to maintain product integrity and safety. This role requires a detail-oriented individual with a strong commitment to upholding rigorous quality standards in a regulated environment, ensuring our medical devices meet and exceed both industry and customer expectations.

Responsibilities

• Assists in maintaining, supporting and improving Quality Management System.
• Primary responsibility is to support incoming inspection activities as well as provide support to the cross functional teams such as manufacturing, operations, and research and development.
• Support design, development, manufacture, and maintanance 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, and Research & Development to drive continuous improvement through business and quality objectives and resolve issues that could impact product quality or regulatory compliance.
• Provide Quality support for production; addresses non-conformances through the NCMR/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.
• Soft skills – a team player, with ability to overlay business constraints and risk diversification over complex issues to determine optimal path to reaching business and quality objectives.
• Perform other duties as assigned

🧭 Qualifications, Skills & Attributes

• 1-2 years of Quality-related experience in the Medical Device industry

• Solid organizational, analytical and problem-solving skills.

• Solid understanding of QSR, MDR, ISO 13485, and 14971.

• Experience performing quality inspections, authoring and reviewing NC records etc.

• Strong computer skills, particularly with eQMS tools, ERP/MRP, MS Office and Adobe Acrobat.

• Excellent interpersonal, communication and presentation skills, both verbal and written

• Reviewing assemblies/drawings in SolidWorks a plus.