Sr Quality Systems Engineer (Field Actions)

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 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.

Preferred Skills and Experience

• 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.
• 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)

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 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.

Mandatory Notices

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. 

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 compensation ranges are listed.