Senior Manager, NPI Quality Engineering

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Groningen, Netherlands

Job Description

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: 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

The anticipated base pay range for this position is: €82 900,00 - €144 210,00

Benefits

• annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health.
• service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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