Senior Quality Engineer, Accessories
Are you a seasoned Quality Engineer with a passion for excellence and a drive to improve processes? Do you have experience in the medical device industry and a strong understanding of regulations and standards? If so, Intuitive Surgical is seeking a Senior Quality Engineer for our Accessories team. Our company is a leader in robotic-assisted surgical technology and we are looking for a highly skilled individual to ensure the quality and reliability of our accessories. Join our dynamic team and make a difference in the lives of patients and healthcare professionals worldwide.
- Develop and maintain quality standards and processes for the Accessories team at Intuitive Surgical.
- Ensure compliance with all applicable regulations and standards, including ISO 13485 and FDA requirements.
- Conduct internal audits to identify areas for improvement and implement corrective actions.
- Collaborate with cross-functional teams to design and implement effective quality control measures.
- Conduct risk assessments and implement risk management strategies for new and existing accessories.
- Monitor and analyze quality data to identify trends and areas for improvement.
- Lead investigations and root cause analyses for quality issues and implement effective corrective and preventive actions.
- Develop and maintain quality documentation, including standard operating procedures and work instructions.
- Train team members on quality processes and procedures to ensure consistent understanding and adherence.
- Stay updated on industry trends and regulatory changes to continuously improve quality processes and ensure compliance.
- Drive continuous improvement initiatives to enhance efficiency and effectiveness of quality processes.
- Act as a subject matter expert on quality-related inquiries and provide guidance to team members.
- Participate in product development and design reviews to ensure quality and reliability standards are met.
- Collaborate with suppliers to ensure quality of materials and components used in accessories.
- Communicate with customers and address any quality concerns or issues in a timely manner.
Extensive Experience In Quality Engineering: A Senior Quality Engineer For Accessories At Intuitive Surgical Should Have A Minimum Of 8-10 Years Of Experience In Quality Engineering, With A Strong Focus On Medical Devices And Accessories.
Knowledge Of Regulatory Requirements: The Ideal Candidate Should Have A Thorough Understanding Of Fda Regulations And International Medical Device Standards, Such As Iso 13485 And Mdd/Mdr.
Strong Problem-Solving Skills: As A Senior Quality Engineer, This Role Requires The Ability To Identify And Resolve Complex Quality Issues, Using Both Analytical And Creative Problem-Solving Techniques.
Project Management Expertise: The Candidate Should Have A Proven Track Record Of Successfully Managing Multiple Projects And Initiatives Simultaneously, While Adhering To Strict Timelines And Budgets.
Excellent Communication And Collaboration Skills: This Role Involves Working Cross-Functionally With Various Teams, Including R&D, Manufacturing, And Regulatory Affairs. Strong Communication And Collaboration Skills Are Essential For Effectively Coordinating And Executing Quality-Related Activities.
Product Development
Quality Assurance
Process Improvement
Quality Management
Quality
statistical analysis
Six sigma
Failure Analysis
Root Cause Analysis
Risk assessment
Regulatory compliance
Supplier Quality
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Quality Engineer, Accessories in Sunnyvale, CA, USA is $100,000-$140,000 per year. However, this can vary depending on factors such as the company, level of experience, and additional skills and certifications. Some companies may offer higher salaries for this position, while others may offer lower salaries. It is important to research and compare different job listings to get a better understanding of the specific salary range for this role in Sunnyvale.
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Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.
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