Staff Quality Engineer

Johnson & Johnson•Jacksonville, FL

1d•$94,000 - $151,800

About The Position

This role combines Technical Review Board leadership with Global Change Control governance in Johnson and Johnson Vision (JJV &JJSV). The position is responsible for leading TRB discussions, ensuring compliant and efficient change management, and driving continuous improvement across quality systems. Exceptional communication skills, the ability to facilitate challenging conversations, and a strong leadership presence are required for this role. In-depth knowledge of medical device Quality Management Systems (QMS), Risk Management, and Change Management processes is expected, along with the confidence to challenge assumptions and guide stakeholders toward quality and compliance outcomes.

Requirements

Bachelor’s degree in Engineering or related field.
6+ years of medical device quality engineering experience.
Communication
Compliance Management
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
System Audits
Systems Analysis

Nice To Haves

Agility Jumps
Analytical Reasoning
Analytics Dashboards
Coaching
Collaborating
Data Compilation
Data Quality
Data Savvy
Quality Services

Responsibilities

Lead and moderate Technical Review Board meetings and document decisions
Administer and improve Global Change Control processes
Ensure compliance with ISO 13485, 21 CFR 820, and ISO 14971
Partner cross-functionally to assess and mitigate risk
Track metrics and drive continuous improvement initiatives.
The role is required to drive improvements and Cycle time within the process in the process in SV and VC for Change control
The Role will also drive a new system integration in Visioncare
Work with originator and SMEs to explain required changes.
Connect across engineering, RA/QA, operations, and manufacturing teams.
Communicate confidently and push back when quality is at risk.
Identify workflow inefficiencies and propose improvements.
Recommend enhancements to TRB and change control processes.
Drive continuous improvement initiatives.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year