Senior Manager, NPI Quality Engineering

Johnson & Johnson is looking for a Senior Manager, New Product Introduction Quality Engineer in Groningen.

SCOPE:

Leads the New Product Quality Engineering (NPQE) function within R&D, overseeing quality systems and compliance activities related to new product introductions. Responsible for ensuring adherence to design controls, CTQ flow-down, validation, and risk management requirements while driving cross-functional alignment and quality excellence. Manages and develops team performance, fosters cross-functional collaboration, and serves as a technical and strategic leader. Ensures compliance with global regulations including FDA, ISO 13485, and EU MDR.

DUTIES & 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.

EXPERIENCE & EDUCATION

· 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.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES

· Strong knowledge of FDA and international regulatory requirements.

· Expertise in design controls, validation, and risk management.

· Proven leadership and team management skills.

· Excellent communication and interpersonal skills.

· Strong analytical and problem-solving abilities.

· Proficiency in Microsoft Office tools.

· Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

LOCATION & TRAVEL REQUIREMENTS

Location: Groningen

Travel: May be required to support global initiatives

Required Skills:

New Product Development, Quality Control (QC), Quality Validation

Preferred Skills:

Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility