Process Quality Leader: Drive Quality & Excellence

6045-Ethicon Inc. Legal Entity; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Johnson & Johnson seeks a Process Quality Leader to provide quality and technical leadership for manufacturing operations. You will identify non-conformances, investigate CAPAs, and drive continuous improvement with Manufacturing, Engineering, and Quality teams.

You will lead cross-functional quality initiatives, develop teams, and ensure compliance with QSR, GMP, ISO standards, and internal requirements while coaching supervisors and aligning with business goals.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Experience in a regulated manufacturing environment (medical device preferred).
• Strong knowledge of FDA QSR, GMP, and ISO requirements.
• Experience with quality investigations, CAPA, root cause analysis, and process improvement methodologies.
• Strong analytical, communication, and problem-solving skills.
• Proficiency with Microsoft Office and data analysis tools.
• Lean Six Sigma certification or equivalent continuous improvement experience.

Responsibilities

• Lead investigations of non-conformances, process failures, complaints, and quality trends.
• Drive root cause analysis and CAPA implementation.
• Ensure compliance with QSR, GMP, ISO, and internal quality requirements.
• Support audits, inspections, and quality system assessments.
• Review quality data and trends to identify opportunities for improvement.
• Partner with Manufacturing and Engineering to improve process capability and product quality.
• Lead continuous improvement initiatives using Lean, Six Sigma, and statistical analysis.
• Develop and maintain procedures, protocols, and training materials.

Skills

Agile Manufacturing

Chemistry

Manufacturing

and Control (CMC)

Coaching

Controls Compliance

Data Gathering and Analysis

Detail-Oriented

Developing Others

Document Management

Financial Competence

Goal Attainment

Good Manufacturing Practices (GMP)

Inclusive Leadership

Leadership

Operational Excellence

Plant Operations

Process Control

Quality Management Systems (QMS)

Quality Standards

Quality Systems Documentation

Time Management

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Preferred Master's degree in Engineering, Science, or related field

Tools

Microsoft Office

Data analysis tools

Job description

Johnson & Johnson seeks a Process Quality Leader to provide quality and technical leadership for manufacturing operations. You will identify non-conformances, investigate CAPAs, and drive continuous improvement with Manufacturing, Engineering, and Quality teams.

You will lead cross-functional quality initiatives, develop teams, and ensure compliance with QSR, GMP, ISO standards, and internal requirements while coaching supervisors and aligning with business goals.