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

JOIN JOHNSON & JOHNSON AS A QUALITY SYSTEMS LEAD IN NIJMEGEN, NETHERLANDS!

Are you ready to lead the charge in quality and compliance at a global healthcare leader? Johnson & Johnson is seeking a highly motivated and experienced Quality Systems Lead to join our innovative team in Nijmegen, Netherlands. This is an incredible opportunity to impact healthcare on a worldwide scale by ensuring our operations meet the highest standards of quality, integrity, and regulatory compliance.

ABOUT THE ROLE

As the Quality Systems Lead, you will play a pivotal role in shaping and maintaining our quality management systems, ensuring adherence to industry regulations, and driving continuous improvement initiatives. You’ll work alongside a team of dedicated professionals, contributing your expertise to elevate our quality standards and support our mission to improve lives globally.

KEY RESPONSIBILITIES

• Develop and implement strategic quality and compliance initiatives aligned with organizational objectives.
• Manage and oversee the implementation and administration of Quality Management Systems (QMS) compliant with relevant standards, regulations, and industry best practices.
• Lead and mentor a team of talented quality professionals, fostering a culture of excellence and continuous learning.
• Maintain and improve core quality processes, including:
• CAPAs and Non-Conformities
• Change Control & Document Control
• Quality Planning
• Site Management Reviews
• Lead Internal Audit programs to ensure ongoing compliance and readiness.
• Collaborate cross-functionally with Operations, Regulatory Affairs, Engineering, and other departments to promote quality awareness and adherence.
• Provide expert guidance in resolving complex quality and compliance issues, escalating relevant business opportunities or risks.
• Stay informed about evolving industry regulations, standards, and innovative practices across global markets (including 21 CFR Part 820, ISO 13485, EU MDR, Canada’s CMDR, J-PAL, Brazil GMP, and other regional standards).

️ What You Bring

• Bachelor’s degree in a technical, scientific, or related field.
• Proven experience in the Medical Device industry with a track record in quality assurance and regulatory compliance.
• Deep understanding of global regulations such as 21 CFR Part 820, QSR, ISO 13485, EU MDR, CMDR, J-PAL, and Brazil GMP.
• Strong leadership and team management skills, with an ability to inspire and develop others.
• Excellent communication and interpersonal skills, capable of engaging stakeholders at all levels.
• A strategic mindset with a strong attention to detail and problem-solving capabilities.