Desired start date: ASAP
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.
Your Core Responsibilities
Maintain and improve QMS Procedures, work instructions, processes and records. Assist in selecting, qualifying and maintaining suppliers and associated efforts within the company's QMS, including conducting supplier evaluations and collaborating with Purchasing.
Collaborate with R&D and Operations to conduct incoming component inspection and execute processes related to non-conformances and supplier-related issues.
Your Day-to-day Activities
• Maintain and improve QMS Procedures, work instructions, processes and records.
• Assist in selecting, qualifying and maintaining suppliers and associated efforts within the company's QMS, including conducting supplier evaluations and collaborating with Purchasing. • Collaborate with R&D and Operations to conduct incoming component inspection and execute processes related to non-conformances and supplier-related issues. • Monitor and assess supplier performance metrics, providing actionable feedback to maintain or exceed quality standards. • Initiate and contribute to continuous improvement projects focused on enhancing supplier processes and overall quality performance. • Contribute to broader quality initiatives, including incoming inspection, Corrective and Preventive Actions (CAPA), documentation reviews, and audit preparation/support.
How You’ll Fit In
You will be working closely with the V&V, Quality and Operations Teams, and under the supervision of the Chief Quality & Regulatory Officer.
Bachelor’s Degree in related field (engineering, life sciences)
3+ years’ experience in Medical Devices, IVD’s or other Life Sciences operating in an FDA/13485 environment.
Solid organizational, analytical and problem-solving skills.
Self-motivated and detail-oriented, with the ability to manage multiple priorities.
Working knowledge of FDA QSR and ISO 13485 and EU MDR. Experience with CAPA, auditing, inspection, and document control.
Strong computer skills, particularly with MES, PLM, Minitab or JMP, ERP/MRP, MS Office and Adobe Acrobat.
Excellent interpersonal and communication skills for effective collaboration with suppliers and cross-functional teams.
25 Days of Paid Vacation
10 Paid Holidays
401k with matching
Competitive Vision, Dental, and Health benefits
Regular national and international travel required (20% of the time)
