PMS Quality Engineer

Intuitive; Bengaluru; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Intuitive is seeking a Regulatory Post Market Surveillance Quality Engineer (RPMS QE) to join the Post Market team. You will analyze product performance, drive RCA, and support improvements across regulatory and quality processes in line with 21 CFR 820 and ISO 13485.

Reporting to the Manager, you will partner with engineering, operations, and clinical teams to investigate complaints, quality issues, and field events, ensuring timely escalation and effective resolution across the closed-loop QMS.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• Experience with quality systems and continuous improvement.
• Strong problem-solving and analytical skills.

Responsibilities

• Process complaint investigations and support quality improvements.
• Collaborate with SMEs on investigations and regulatory responses.
• Evolve processes to enable timely escalation in QMS.
• Collect and analyze data, perform root cause analyses.
• Participate in internal/external audits for Post Market.

Skills

Quality Engineering

Problem Solving

Data Analysis

Cross-functional Collaboration

Communication Skills

Root Cause Analysis

Education

Bachelors in Engineering

Tools

Lean

Six Sigma

Quality Regulations 21 CFR 820

Job description

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies- like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful- because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

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.

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

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.

Shift: Day