Impact-Driven Senior Validation Quality Engineer

Johnson & Johnson Innovative Medicine; Jacksonville (FL); On-site; USD 100,000 - 130,000; Full time

Job summary

Johnson & Johnson, Vision a member of the Johnson & Johnson Family of Companies, is recruiting a Senior Validation Quality Engineer, Quality Operations for Jacksonville, FL. This role ensures FDA/GMP and ISO 9001 compliance and leads validation activities across product, process, and equipment changes.

The Senior Quality Engineer analyzes quality trends, supports quality management systems, and collaborates with cross-functional teams to prevent recurrence of issues while maintaining meticulous

Qualifications

• 5–9 years in medical device/pharma QA or regulatory fields.
• Deep knowledge of ISO/FDA regulatory requirements.
• Strong analytical and communication skills; data-driven problem solving.

Responsibilities

• Facilitate complex validation activities for product, process, equipment, software and facilities changes.
• Track quality performance and prioritize improvements using quality tools.
• Apply a risk-based validation strategy and assess change requests.
• Represent QA in validation across multi-department meetings and change control.
• Compile data and report to management on a periodic basis.
• Develop and train on quality concepts, policies, and systems.
• Develop sampling plans using attribute, variable, and sequential methods.
• Support updates to quality documentation.
• Perform other related duties as assigned by management.

Skills

Root cause analysis

Regulatory knowledge

Quality Assurance

Data analysis

Communication skills

Problem-solving

Education

Bachelor’s Degree in Science/Engineering/Business

Master’s degree preferred

Tools

Statistical software

Job description

Johnson & Johnson, Vision a member of the Johnson & Johnson Family of Companies, is recruiting a Senior Validation Quality Engineer, Quality Operations for Jacksonville, FL. This role ensures FDA/GMP and ISO 9001 compliance and leads validation activities across product, process, and equipment changes.

The Senior Quality Engineer analyzes quality trends, supports quality management systems, and collaborates with cross-functional teams to prevent recurrence of issues while maintaining meticulous