PMS Quality Engineer

Job Description

Primary Function of the 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.

Essential Job Duties

• Reporting to the 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.

Required Skills and Experience

• Minimum 5 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.

#LI-Hybrid

Qualifications

Required Education and Training 

• Bachelor's degree (Engineering or equivalent)

Preferred Skills and Experience 

• Knowledge of Quality Systems Regulations (21 CFR 820) and ISO 13485 preferred.
• 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.
• Project Management experience preferred.

Additional Information

Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.