Senior Validation Quality Engineer — GMP/ISO Expert

Johnson & Johnson Co.; Jacksonville (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Validation Quality Engineer, Quality Operations, based in Jacksonville, FL.

The Senior Quality Engineer ensures operational compliance to FDA/GMP and ISO 9001 regulations, analyzes quality trends, and supports the quality management system across multiple departments. You will lead validation activities and collaborate to prevent recurrence of issues.

Qualifications

• 5–9 years of industry experience in medical device or pharmaceutical QA/regulatory fields.
• In-depth understanding and application of ISO/FDA regulatory requirements.
• Excellent organizational, interpersonal, written, and oral communication skills.
• Root cause analysis experience required.
• Data-driven with knowledge of Process Excellence, Statistical Process Control and Applied Statistics.

Responsibilities

• Facilitates complex validation activities across product, process, equipment, software and facilities changes.
• Tracks quality performance and identifies opportunities for improvement.
• Applies risk-based validation strategy and evaluates change requests.
• Represents QA in validation and change-control meetings.
• Compiles data and provides management reports on a periodic basis.
• Develops quality policies and conducts training on quality concepts and tools.
• Reviews and supports updates to quality documentation and procedures.
• Develops sampling plans using attribute, variable, and sequential methods.
• Performs other duties as assigned by management.

Skills

Quality Assurance

Root cause analysis

Data analysis

Process Excellence

Statistical Process Control

Applied Statistics

Project management

Communication skills

Education

Bachelor's Degree - Science/Engineering/Business

Master's degree preferred

Job description

Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Validation Quality Engineer, Quality Operations, based in Jacksonville, FL.

The Senior Quality Engineer ensures operational compliance to FDA/GMP and ISO 9001 regulations, analyzes quality trends, and supports the quality management system across multiple departments. You will lead validation activities and collaborate to prevent recurrence of issues.