Intuitive
medical device
SrQualitySystemsEngineer(FieldActions)
Neural analysis suggests this role is
optimal for mid candidates.
“Sr Quality Systems Engineer (Field Actions) at Intuitive. Skills: Quality Systems, Compliance, Field Actions, Regulatory Affairs, Medical Device Regulations. Compliance representative on product issue escalation meetings. Understanding product/process issues, risk, and clinical impact”
What You'll Achieve.
fulfillment of company quality goals and objectives; ensure quality system issues are appropriately escalated and addressed
Industry & Context.
critical thinking skills; issue resolution
Proof of vaccination against certain diseases including COVID-19 may be required., May be subject to U. S. export controls., Consideration for qualified applicants with arrest and conviction records., Preference 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.
What They're Looking For.
Must Have
Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field, Minimum 10 plus (10+) years’ experience in product quality or regulatory compliance (or combined experience) in the medical device or other regulated industry, Applied understanding of applicable US medical device regulations (e. g. , 21 CFR Part 820, 21 CFR Part 11), international standards (e. g. , ISO 13485, ISO 14971), and international regulations (e. g. , CMDR – Canada, European, RDC – Brazil), Experience with computer regulations/standards and methodologies, Experience in developing and implementing processes and procedures to comply with regulations and standards across the and providing training, organizational, written, and verbal communication plus critical thinking skills and proficient in constructive dialogue, Effective at prioritizing of tasks and responsibilities within a fast-paced, dynamic environment, Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness, Good understanding of failure analysis and product, application of risk management with respect to post-market surveillance., Practiced in presenting to various levels of management
Nice to Have
1-2 years direct experience in field actions/recalls in Medical Device Industry is strongly preferred., Demonstrated leadership and partnership in working with diverse teams for improvements, issue resolution, or projects, Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred), Applied knowledge of validation methodologies pertaining to computer system, process and equipment (preferred), Six Sigma Greenbelt certification or other professional certification (e. g. , ASQ certification) (preferred)
What You'll Do.
Compliance representative on product issue escalation meetings
Understanding product/process issues
Establishing escalation decisions/conclusions
Providing guidance in the interpretation of FDA regulations and external regulations/standards
Assessing the need and requirements for field actions
Authoring and reviewing follow-up questions and responses related to field actions from regional regulators
Providing guidance on ad-hoc product/compliance questions
Researching regulations
current processes/practices
and industry/regulatory agency expectations
Participating in process improvements
Proactively identifying and anticipating risk of non-compliance
Ensuring conformance to regulatory requirements
Providing leadership for Quality Systems and Compliance projects and personnel
Ensuring fulfillment of company quality goals and objectives
Supporting facility inspections and audits
Providing backroom leadership during external audits
Performing assessments
developing action plans
and driving/facilitating implementation activities for new requirements
Supporting business partners and QSC group in determining risk-based actions and decisions
Ensuring quality system issues are appropriately escalated and addressed
Collaborating in development
and improvement of processes and procedures
Providing training on quality management system processes
Collaborating with OUS ISI sites in the harmonization of primary quality system processes
Leading primary quality initiatives within the quality systems
How You'll Work.
Team & Collaboration
Compliance representative on product issue escalation meetings; Guidance to stakeholders; Collaborate in development, maintenance, and improves processes and procedures; Collaborates with OUS ISI sites in the harmonization of primary quality system processes; Demonstrated leadership and partnership in working with diverse teams for improvements, issue resolution, or projects; Collaborating and partnering with all levels of management
Communication Scope
organizational, written, and verbal communication; proficient in constructive dialogue; Practiced in presenting to various levels of management
Process & Methodology
Providing leadership for Quality Systems and Compliance projects, Developing action plans, Driving/facilitating implementation activities
Full Job 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. Essential Job Duties * Compliance representative on product issue escalation meetings to understand the product/process issue, risk, clinical impact and help establish escalation decisions/conclusions. * Provides guidance to stakeholders in the interpretation of FDA regulations and external regulations/standards pertaining to assessing the need and requirements for field actions. * Help author and review any follow-up questions, responses related to the field actions from regional regulators. * Help provide guidance on a variety of ad-hoc product/compliance questions, including helping research the regulations, current process/practices within ISI, industry/regulatory agency expectations etc. * Participate in process improvements, streamlining and scalability associated with above processes. * Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. * Provides leadership for Quality Systems and Compliance project
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