Intuitive
medical device
SrQualitySystemsEngineer(FieldActions)
Neural analysis suggests this role is
optimal for mid candidates.
“Sr Quality Systems Engineer (Field Actions) at Intuitive. Skills: product quality, regulatory compliance, field actions, recalls, risk management, FDA regulations, international standards. 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 assessi”
What You'll Achieve.
ensure the fulfillment of company quality goals and objectives; ensure quality system issues are appropriately escalated and addressed
Industry & Context.
critical thinking skills; failure analysis
may require proof of vaccination against certain diseases including COVID-19, subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date
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, Demonstrated leadership and partnership in working with diverse teams for improvements, issue resolution, or projects, 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., 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 to understand the product/process issue
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 projects and personnel to ensure the fulfillment of company quality goals and objectives
Support facility inspections and audits required by government and regulatory agencies on a global basis.
Works with Audit Management on maintaining audit readiness for internal and external provides backroom leadership during external audits.
develops action plans
and drives/facilitates implementation activities to address new requirements from global standards or regulations.
Supports business partners and QSC group in determining risk-based actions and decisions to ensure quality system issues are appropriately escalated and addressed.
Collaborate in development
and improves processes and procedures for various processes within the quality management system and where necessary
Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate
leads primary quality initiatives within the quality systems.
How You'll Work.
Team & Collaboration
Demonstrated leadership and partnership in working with diverse teams for improvements, issue resolution, or projects; Effective in collaborating and partnering with all levels of management; Supports business partners and QSC group in determining risk-based actions and decisions; Collaborate in development, maintenance, and improves processes and procedures; Collaborates with OUS ISI sites in the harmonization of primary quality system processes
Communication Scope
organizational, written, and verbal communication; proficient in constructive dialogue; Practiced in presenting to various levels of management
Process & Methodology
Provides leadership for Quality Systems and Compliance projects and personnel, develops action plans, drives/facilitates 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. 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 Essential Job Duti
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