Sr Quality Systems Engineer (Field Actions)

Intuitive•Sunnyvale, CA

About The Position

This role serves as a Compliance representative on product issue escalation meetings, understanding product/process issues, risks, and clinical impact to aid in escalation decisions. The position provides guidance to stakeholders on interpreting FDA regulations and external standards related to field actions. The engineer will also help author and review responses to regulators, provide guidance on ad-hoc product/compliance questions, and participate in process improvements for associated processes. A key aspect of this role is proactively identifying and anticipating risks of non-compliance in a dynamic environment, ensuring conformance to regulatory requirements, internal processes, and policies. The role supports facility inspections and audits, works with Audit Management on audit readiness, and performs assessments to address new regulatory requirements. Collaboration with business partners and the QSC group is essential for determining risk-based actions and decisions. The engineer will also contribute to the development, maintenance, and improvement of quality management system processes and procedures, and may provide training. Collaboration with OUS ISI sites for harmonization of quality system processes and leading quality initiatives are also part of the responsibilities.

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.
Practiced in presenting to various levels of management

Nice To Haves

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.