Quality Engineer

Johnson & Johnson Innovation; Leiden; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Service awards

Job summary

Johnson & Johnson in Leiden seeks a Quality Engineer to ensure GMP-compliant quality management within the DSP CoE. You will lead non-conformance investigations, CAPA records, and Change Controls from initiation to completion, owning timelines and driving timely resolutions.

You will review quality documentation, support audits, and collaborate with stakeholders to enable continuous improvement and robust quality systems across operations.

Qualifications

• HBO degree with 3+ years of quality, manufacturing or GMP-regulated experience.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis and data analysis.
• Excellent communication and stakeholder management skills; fluent English (B2).

Responsibilities

• Apply Quality expertise to support Operations objectives, ensuring GMP compliance.
• Lead non-conformance investigations, CAPA records, and Change Controls end-to-end.
• Review and maintain quality documentation and records; support audits and inspections.
• Drive continuous improvement through risk mitigation, GEMBA walks, data analysis, and quality projects.
• Collaborate with stakeholders to ensure effective quality activities.

Skills

GMP

CAPA

Change Control

Quality Systems

Root Cause Analysis

Risk Management

Data Analysis

MS Office

Fluent English

Education

HBO degree in Quality/Engineering

Tools

MS 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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

As a Quality Engineer within the DSP CoE department, you'll be pivotal in ensuring our quality management systems are top-notch. You'll apply quality requirements to support the execution of Operations unit objectives. Your role will involve performing nonconformance investigations, including CAPA records, and leading change controls from initiation through completion. This role requires someone who takes clear ownership of records, makes sure accountability for timelines, and drives timely, sustainable resolutions

Responsibilities

• Apply Quality expertise to support Operations objectives, ensuring compliance with GMP and quality management requirements.
• Lead and manage non-conformance investigations, CAPA records, and Change Controls from initiation through completion, ensuring timely and sustainable resolution of issues.
• Review and maintain quality documentation, procedures, and records, ensuring compliance with regulatory requirements, audits, and internal standards.
• Drive continuous improvement through risk mitigation initiatives, GEMBA walks, data analysis, and quality improvement projects while escalating quality, safety, and compliance risks as needed.
• Support audits and inspections, develop GMP training initiatives, and collaborate with stakeholders to ensure effective communication and execution of quality activities.

Requirements

• HBO degree with 3+ years of relevant Quality, Manufacturing, or GMP-regulated industry experience, including experience leading or supporting quality investigations and change controls.
• Strong knowledge of GMP, CAPA, Change Control, quality systems, root cause analysis, risk management, and data analysis; proficient in MS Office and business applications.
• Excellent communication, stakeholder management, analytical thinking, prioritization, and problem-solving skills; fluent English (B2), highly organized, accountable, adaptable, and able to perform effectively under pressure.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Required Skills:

Preferred Skills:

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy

The anticipated base pay range for this position is:

€44.700,00 - €70.840,00

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.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.