Regulatory Post Market Surveillance Quality Engineer

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

The Post Market team at Intuitive works at the intersection of Regulatory and Quality. The team engages across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions. Functions collaborating with the Post Market team include Post Market Surveillance, Field Action, Data Analytics, Clinical Engineering, Field Service, Technical Support, Customer Service, Risk Management, Service Operations, and Failure Analysis Engineering. The Post Market Team advocates for safety and effectiveness improvements by assessing field product performance and QMS processes to identify, investigate, communicate, and execute on opportunities. The Post Market team requires a Quality Engineer with strong hands-on experience in problem solving, technical savvy with complex electro-mechanical devices, proficient technical writing ability and passion for the best practices to analyze, monitor, and improve both product and process.

Roles & Responsibilities:

• Reporting to the Sr. Manager, Regulatory Post Market Surveillance, the Regulatory Post Market Surveillance Quality Engineer (RPMS QE) is responsible for processing Complaint Investigations; partnering across the organization to identify and support continuous process/quality improvement programs that strongly align with Intuitive standards and customer needs while meeting all applicable Medical Device Regulations and Standards.
• Partner with subject matter experts on various activities related to complaint investigations, escalated field events, or regulatory response letters.
• Evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality management system.
• The RPMS QE will work to collect and analyze data, drive rigorous root cause analyses and facilitate cross-functional discussions to ensure we are seeing 'all the way around' issues for complete resolution.
• Participate in internal/external audits as necessary representing the Post Market Program.

Qualifications

Skills, Experience, Education, & Training:

• Minimum education: Bachelor's degree (Engineering or equivalent) combined with minimum 3 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
• Must have working experience of Quality Systems Regulations (21 CFR 820) and ISO 13485.
• Strong interpersonal and communication skills:
  • Passionate about making products and processes better.
  • Able to assist people in finding creative solutions around constraints.
  • Able to deliver presentations to a broad audience.
• Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus.
• Experience gathering/processing internal and external requirements.
• Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results.
• Proven ability to investigate issues and drive creative problem solving related to product/process issues and effectively document as needed.
• The ability to collaborat