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Post Market Surveillance Quality Engineer
hace 2 meses
About Intuitive
At Intuitive, we are united behind our mission: we believe that minimally invasive care is care that improves lives. Through innovation and intelligent technology, we expand the potential of physicians to heal without limits.
Our Culture
We are pioneers and market leaders in robotic surgery, striving to foster an inclusive and diverse team committed to making a difference. For over 25 years, we have worked with hospitals and healthcare teams worldwide to help solve some of the toughest challenges in healthcare and advance what is possible.
Our Values
We believe that great ideas can come from anywhere: we strive to cultivate an inclusive culture based on diversity of thought and mutual respect. We lead with inclusion and train our team members to work at their best and express their authentic selves.
Our Team
Passionate individuals who want to make a difference drive our culture: our team members are based on integrity, have a solid ability 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 and continue advancing our mission and reaching their full potential.
About the Role
Job Summary
The Post Market Surveillance Quality Engineer will work at the intersection of Regulatory and Quality, engaging across the organization to deeply understand how our products and processes perform, the implications of any issues, and support the execution of robust resolutions.
Key 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.
- Evolving 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.
- Participating in internal/external audits as necessary representing the Post Market Program.
Requirements
Qualifications
Required Skills and Experience
- Bachelor's degree (Engineering or equivalent)
- Minimum 3 years of related experience in Quality, Engineering, Operations, or a continuous improvement environment.
- 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
- 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 collaborate effectively with product and/or process subject matter experts in a cross-functional team environment is required.
- Technical aptitude is required to collect and analyze data for determining an improvement strategy.
- Ability to navigate multiple projects with changing priorities. Ability to execute to project timelines.
- Ability to travel up to 10% of the time.
