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QA Engineer 3

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

As Intuitive’s da Vinci® Surgical System becomes adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process.

The position is a Quality Engineer-3 based out of Peachtree corners, GA and will support manufacturing and remanufacturing of systems for the Davinci Multiport (MP) business unit.

Essential Job Duties:

  • Initial roles and responsibilities for this position will include the following:
  • 60% involvement in supporting sustaining manufacturing operations, 25% design controls and 15% quality advocacy (quality improvements).
  • Manufacturing support:
    • Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containments.
    • Ensure manufacturing activities follow ISI procedures and regulations.
    • Support development and execution of process validation and verification test plans, protocols, and reports.
    • Maintain site level process FMEA and risk management files and update as required.
    • Support production ramp and work cross functionally on issue and support continuous improvement projects.
    • Support investigation and disposition of non-conformances, both internal and supplier related.
  • Product development:
    • Support various product and subsystem type design changes (not a full design quality support)
    • Participate in risk management process ensuring that the essential performance aspects are correctly mitigated in the product quality plans.
    • Ensure design changes are established and implemented according to ISI standards and applicable regulations.
    • Recommend design processes and methods to meet quality goals (DFX, etc.).
  • Quality Advocacy:
    • Develop and apply corporate-level quality metrics.
    • Ensure the quality system requirements are effectively established and maintained.
    • Lead and manage quality initiatives in one or more areas of product and processes quality.
    • Evaluates deviations and non-conformances and supports resolution of quality issues
    • Supports process validation and verification.
  • Perform risk analysis and determines quality disposition for variance requests and non-conformances
  • Represents the department cross-functionally in meetings that may include senior and external personnel
  • Releases process and document changes through engineering change orders and deviations using ISI change control process
  • Escalates to direct management all quality issues that could impact patient safety or surgical efficacy
  • Ensures successful, on-time completion of department projects, communicates constraints to direct management when successful project completion is at risk.
  • Performs other duties as assigned by the management.

Qualifications

Required Skills and Experience

  • Competency Requirements: In order to adequately perform the responsibilities of this position the individual must possess:
  • Minimum Education: Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred.
  • 4+ years of relevant experience in medical device or manufacturing environment.
  • Demonstrated proficiencies of CFR 21 820/ ISO 13485 requirements for making process or design changes.
  • Understands product risk management, experience in generate FMEA and process FMEA.
  • Understands Design Controls, Change Controls, Product, and Engineering Processes.
  • Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures.
  • Experienced in leading product containment and rework activities.
  • Proficient in SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).
  • Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) Able to create Multi-source report, trends, and interprets data with minimal oversight.
  • Capable of thinking independently and make decision based on limited information.
  • Ability to communicate effectively both verbally and in writing Integrity: Accepting and adhering to high ethical, moral, and personal dealing with others values in decisions, communications, actions, and when Dealing with others
  • Ability to work independently and handle tasks with competing priorities effectively.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action 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.

EEO and AA Policy

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

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Average salary estimate

$90000 / YEARLY (est.)
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$100000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About QA Engineer 3, Intuitive

If you're a passionate QA Engineer 3 looking for an exciting opportunity at Intuitive in Peachtree Corners, GA, then this is the role for you! At Intuitive, we are dedicated to improving minimally invasive care through advanced robotic-assisted surgery. We're on the lookout for someone who thrives in a hands-on environment, ready to tackle complex electro-mechanical systems that directly impact the healthcare landscape. In this dynamic role, you'll spend 60% of your time supporting our thriving manufacturing operations. Your responsibilities will include collaborating on failure analysis, documenting essential processes, and ensuring all activities align with our rigorous ISI procedures. You'll contribute significantly by executing process validation and verification plans while maintaining our site’s risk management files. On the product development front, you'll help ensure that design changes adhere to ISI standards and address quality goals effectively. And let's not forget about quality advocacy, where you'll develop corporate-level metrics to enhance overall quality assurance across the organization. If you're excited about finding innovative solutions and leading quality initiatives at a pioneering company, Intuitive needs you on our team to help us continue to push the boundaries of what's possible in healthcare!

Frequently Asked Questions (FAQs) for QA Engineer 3 Role at Intuitive
What are the day-to-day responsibilities of a QA Engineer 3 at Intuitive?

As a QA Engineer 3 at Intuitive, your day-to-day responsibilities will primarily focus on supporting manufacturing operations, executing failure analysis, and validating manufacturing processes. You'll also be involved in the quality advocacy side, where you'll develop metrics and collaborate on design changes to ensure compliance with quality standards. Your contributions will be crucial in maintaining the effectiveness of the quality system.

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What qualifications are required for a QA Engineer 3 position at Intuitive?

To qualify for the QA Engineer 3 role at Intuitive, candidates should possess at least a bachelor’s degree in engineering, math, or physics, alongside a minimum of four years of relevant experience in the medical device or manufacturing sectors. Strong knowledge of CFR 21 820 and ISO 13485 standards, as well as proficiency in Six Sigma methodologies, are also essential.

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What makes working at Intuitive as a QA Engineer 3 unique?

Working at Intuitive as a QA Engineer 3 is unique due to our commitment to innovation in minimally invasive care. You'll be part of a team at the forefront of medical technology, helping design and manufacture robotic surgical systems that enhance patient outcomes. The inclusive culture fosters creativity and respect, allowing you to thrive and make a significant impact in healthcare.

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How does Intuitive support the growth of its QA Engineer 3 team members?

At Intuitive, we are dedicated to the long-term growth of our QA Engineer 3 team members. We provide ongoing training and development opportunities, mentorship programs, and access to various resources that will aid in skill enhancement and professional advancement. We believe in empowering our team to pursue their highest potential while fostering a culture of continuous improvement.

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What kind of projects will a QA Engineer 3 at Intuitive work on?

A QA Engineer 3 at Intuitive will work on various projects, including supporting manufacturing operations, engaging in the risk management process, and advocating for quality improvements across products and processes. Your role will also involve collaborating with teams to address non-conformances and participating in design change processes, ensuring that our products are safe and effective for surgical applications.

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Common Interview Questions for QA Engineer 3
How do you approach quality assurance in a manufacturing environment?

When tackling quality assurance in a manufacturing environment, it’s important to have a systematic strategy. I focus on understanding the manufacturing processes, establishing clear metrics for quality, and promoting communication across teams. Conducting regular audits and utilizing tools like FMEA can help identify potential risks early on, allowing us to implement corrective actions before issues arise.

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Can you explain your experience with ISO 13485 requirements?

My experience with ISO 13485 requirements includes developing and maintaining quality management systems tailored to medical device manufacturing. I ensure that all processes meet the regulatory standards, from design controls to production quality checks. I've actively participated in audits and conducted internal training sessions to reinforce compliance within the organization.

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What strategies do you use for effective problem-solving in QA?

For effective problem-solving in QA, I employ a structured approach that includes root cause analysis and data-driven decision-making. Techniques like the 5 Whys and fishbone diagrams help me clarify underlying issues. Additionally, collaborating with multidisciplinary teams ensures all perspectives are considered, fostering innovative solutions that address core problems comprehensively.

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How do you stay current with regulatory changes in the medical device industry?

I stay current with regulatory changes in the medical device industry by regularly reviewing updates from governing bodies like the FDA and ISO. I also participate in professional organizations, attend industry conferences, and subscribe to relevant journals and newsletters, which help keep me informed about new regulations and best practices to implement within my role.

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Describe a time you successfully led a quality improvement initiative.

One successful quality improvement initiative I led involved implementing a new process validation protocol that reduced product non-conformances by 30%. By collaborating with cross-functional teams, we identified critical process steps that required modification and established better quality metrics to monitor ongoing performance. Communication and engagement were key to the initiative's success, allowing for better buy-in from all stakeholders.

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What is your experience with Six Sigma methodologies and how have you applied them?

I have substantial experience applying Six Sigma methodologies, particularly the DMAIC framework, to improve quality and efficiency in manufacturing processes. For example, I led a project where we identified waste in our production line using Lean principles, and implemented process improvements that decreased cycle time by 20%, while also enhancing product quality. These results solidified my belief in using data to drive quality initiatives.

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How do you prioritize competing tasks in a fast-paced QA environment?

In a fast-paced QA environment, I prioritize competing tasks by assessing their immediate impacts on product quality and compliance. I utilize tools like the Eisenhower matrix to distinguish between urgent and important tasks, ensuring that critical issues are addressed promptly while planning for longer-term projects. Maintaining open communication with my team helps align our immediate efforts with overall quality objectives.

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What role does risk management play in your quality assurance processes?

Risk management is a cornerstone of my quality assurance processes. I employ proactive risk assessments, incorporating tools like FMEA to identify potential risks early. This approach allows me to develop mitigation strategies before issues arise, ensuring a smoother workflow and enhancing product safety. By continuously updating our risk management files, we stay aligned with evolving quality requirements.

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How do you handle non-conformances in the manufacturing process?

When handling non-conformances in the manufacturing process, I first gather all relevant data to understand the nature and scope of the issue. I then coordinate an investigation, involving all stakeholders to determine the root cause and implement corrective actions. I ensure that lessons learned are documented and shared with the team to prevent recurrence, reinforcing a culture of continuous improvement.

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Why do you want to work as a QA Engineer 3 at Intuitive?

I am excited about the opportunity to work as a QA Engineer 3 at Intuitive because of your commitment to advancing minimally invasive surgical care. I admire the company's innovative approach and the potential to contribute to projects that have a significant positive impact on patient outcomes. The collaborative environment and dedication to team growth align perfectly with my professional values and aspirations.

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Founded in 1995, Intuitive Surgical, Inc develops, manufactures and markets robotic technologies designed to improve clinical outcomes and help patients return more quickly to active and productive lives. The company is headquartered in Sunnyvale,...

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Full-time, on-site
DATE POSTED
March 16, 2025

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