Staff Escalation Engineer

Johnson & Johnson

Staff Engineer managing product quality issue escalations for Johnson & Johnson's medical devices. Collaborating with cross-functional teams and supporting regulatory compliance in a hybrid work environment.

Posted 4/23/2026full-timeSan Jose • California, Ohio • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

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)
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 facilitate 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
Support data requests for audits, post market surveillance, regulatory registrations, QSMR, etc
Responsible for all field action activities as Franchise Field Action Coordinator
Coordinate recall strategy plan definition with business stakeholders
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
Act as backup support for product escalation Quality Engineers or other product Field Action teams
Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace
Perform other duties assigned as needed.

Requirements

What you’ll need

University/Bachelors degree or equivalent in scientific and/or engineering discipline
Minimum of 6 years of related work experience
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
Able to communicate effectively at all levels within Quality as well as cross functionally
Work in a fast-paced environment and prioritize multiple issues at a time
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
Excellent interpersonal relations, influence and communication skills are required
Strong oral and written communications skills
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.

Benefits

Comp & perks

Inclusive work environment
Professional development opportunities

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

risk managementISO regulationscGMP regulationsStatisticsSampling PlanningRisk AssessmentProcess Validationfield action processauditscontinuous improvement

Soft Skills

communication skillsinterpersonal relationsinfluenceconflict resolutioncollaborative leadershipadaptabilityprioritizationproblem-solvingteamworkchange management

Certifications

ASQ certificationCQECQMCRECQA