Senior Manager, NPI Quality Engineering

Johnson & Johnson MedTech

Groningen

On-site

EUR 83,000 - 144,000

Full time

7 days ago

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Benefits offered by this job

Annual bonus

Vacations

Parental leave

Well-being programs

Job summary

Johnson & Johnson MedTech in Groningen seeks a Senior Manager, New Product Introduction Quality Engineer to lead the NPQE function within R&D. You will oversee quality systems, ensure design controls, CTQ flow-down, validation, and risk management while guiding cross-functional teams.

The role requires 8–10 years in R&D/Quality/Regulatory with at least 5 years in management, and strong FDA/ISO/MDR knowledge. Location is Groningen with global regulatory responsibility.

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 NPQE 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.
Ensure compliance with global regulatory requirements.
Support environmental, health, and safety objectives.
Perform additional duties as assigned.

Skills

FDA regulations

Design controls

Risk management

Leadership

Communication

Analytical skills

AI awareness

Education

Bachelor’s degree

Tools

MS Office

Job description

All Job Posting Locations

Groningen, Netherlands

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 & 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

The Anticipated Base Pay Range For This Position Is

€82 900,00 - €144 210,00

Benefits

In addition to base pay, we offer the following benefits*: an 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. Moreover, we offer 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. We also offer 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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.