Senior NPI Quality Engineering Leader

8358-AMO Groningen B.V. Legal Entity; Groningen; On-site; EUR 83,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Health benefits

Job summary

Johnson & Johnson in Groningen is seeking a Senior Manager, New Product Introduction Quality Engineer to lead NPQE across platforms. You will guide quality systems, design controls, validation, and risk management, while aligning cross‑functional teams and driving quality excellence.

The role requires 8–10 years in R&D/Quality/Regulatory with at least 5 years in management. Knowledge of FDA/ISO 13485 and EU MDR is essential, with strong communication and leadership skills.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 8–10 years industry experience in R&D, Quality, or Regulatory.
• Minimum 5 years managerial experience.

Responsibilities

• Lead and manage multiple New Product Introduction (NPI) projects across platforms.
• Provide guidance and training on quality systems and development processes.
• Develop and improve quality systems and validation programs.
• Monitor quality program effectiveness and drive continuous improvement.
• Manage and develop team members and ensure accountability.
• Influence cross‑functional stakeholders to drive improvements.
• Serve as technical expert for NPQE and resolve complex issues.
• Ensure compliance with global regulatory requirements.
• Support environmental, health, and safety objectives.
• Perform additional duties as assigned.

Skills

NPI Quality Engineering

Team Leadership

Cross-functional Collaboration

Regulatory Knowledge

Quality Systems

Problem Solving

Education

Bachelor’s Degree in Science/Engineering or related field

Tools

Microsoft Office

Job description

Johnson & Johnson in Groningen is seeking a Senior Manager, New Product Introduction Quality Engineer to lead NPQE across platforms. You will guide quality systems, design controls, validation, and risk management, while aligning cross‑functional teams and driving quality excellence.

The role requires 8–10 years in R&D/Quality/Regulatory with at least 5 years in management. Knowledge of FDA/ISO 13485 and EU MDR is essential, with strong communication and leadership skills.