Quality Engineer

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:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
Scientific/Technology

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 ...