Sr Quality Systems Engineer (Field Actions)

Intuitive•Sunnyvale, CA

About The Position

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.

Requirements

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
1-2 years direct experience in field actions/recalls in Medical Device Industry is strongly preferred.
Demonstrated strong 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 organization; and providing training
Strong organizational, written, and verbal communication skills; 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 investigations; application of risk management with respect to post-market surveillance.

Nice To Haves

Practiced in presenting to various levels of management
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)

Responsibilities

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 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 audits; provides backroom leadership during external audits.
Performs assessments, 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, maintenance, and improves processes and procedures for various processes within the quality management system and where necessary, provides training.
Collaborates with OUS ISI sites in the harmonization of primary quality system processes and where appropriate, leads primary quality initiatives within the quality systems.