Staff Escalation & Field Action Engineer

Johnson & Johnson•San Jose, CA

1d•Hybrid

About The Position

This position will have responsibility for the end-to-end process related to product quality issue escalations through the decision-making framework of risk management and quality review boards to inform and support decisions to initiate field actions when appropriate, as well as for planning, implementing, execution of field actions (FA) for Monarch and Ottava product families. The position will be based either in a Bay Area RAD location or Cincinnati.

Requirements

University/Bachelors degree or equivalent in scientific and/or engineering discipline.
Minimum of 6 years of related work experience
Able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations, Medical Affairs, Medical Safety, Compliance, Manufacturing, etc.
Work in a fast-paced environment and prioritize multiple issues at a time.
Excellent interpersonal relations, influence and communication skills are required.
Strong oral and written communications skills with ability to speak to broad, non‐technical audiences that are both internal and external personnel.
Skilled at preparing executive briefings and broad communications.
Ability to make solid decisions that will effectively support the business and company policies.
Advanced skills on Microsoft Office software, including PowerPoint, is required.
Ability to handle and resolve conflict situations and influence key business stakeholders to deliver mutually beneficial outcomes.

Nice To Haves

Experience in medical device, pharmaceutical or other highly regulated industry preferred.
Knowledge of ISO and/or cGMP regulations is preferred.
An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
Background in medical device capital systems and instrumentation is strongly preferred.
Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
Experience with internal/external audits, Risk Management, and recruiting/onboarding of prospective team members is preferred.
Experience leading collaborative efforts within teams and implementing continuous improvement activities is preferred.

Responsibilities

Execute and lead the overall escalation process from issue identification to presentation at the Risk Management Board (RMB) as well as the Quality Review Board (QRB), when required.
Collect, create and review escalation documentation to ensure robustness and compliance to internal and external requirements.
Prepare meeting content for the Risk Management Board and/or Quality Review Board to help facilitate the determinations of field actions.
Appropriately utilize risk management within the escalation process.
Partner with Quality Operations, Compliance, Regulatory, R&D, Medical Safety, as well as other organizations who may own portions of a given product issue escalation.
Support data requests for audits, post market surveillance, regulatory registrations, QSMR, etc, as well as provide data for periodic reports, presentations, and metrics related to product risk escalations.
Responsible for all field action activities as Franchise Field Action Coordinator.
Coordinate recall strategy plan definition with business stakeholders, coordinate periodic recall meetings with the Field Action team, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of all activities and follow up recall activities to successful completion per established recall strategy.
Responsible for participating in and providing field action inputs to the Quality Review Board for decision in containment/corrections to be implemented in the field.
Manage, maintain, and improve and standardize Field Action process to ensure compliance with FDA regulations, ISO Standards and all applicable regulatory authority requirements
Support internal and external audits in preparation activities and serve as a subject matter expert during audits.
Coordinate and participate in special projects as assigned; act as backup support for product escalation Quality Engineers or other product Field Action teams.
Identify, lead and/or support appropriate projects towards desired business outcomes.
Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.
Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
Perform other duties assigned as needed.