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 **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Nijmegen, Netherlands, Zug, Switzerland **Job Description:** Are you ready to take on a unique and exciting opportunity as a **Senior** **Design Quality Engineer** in the Medical Device Sector? Johnson & Johnson is seeking a highly motivated individual to join our team in Nijmegen, Netherlands. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do. As a **Senior Design Quality Engineer** you will lead the development, implementation, and maintenance of quality assurance processes within the design and development phases of products. In this position you will be responsible for the leadership and support of Quality Engineering activities pertaining to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the innovative synthetic products of the Biosurgery Platform. The ideal candidate shares a passion for ensuring the highest quality experiences for our patients and customers and demonstrates: + An advanced knowledge of Quality Engineering/Scientific Method techniques and principles. + Ability to implement statistics of increasing complexity + Strong technical understanding of manufacturing equipment and processes. + Understanding of new product or process introduction processes, and expertise in process qualifications/validations. + Experience implementing appropriate risk mitigation with knowledge of product or process and process Risk Management (FDA & ISO standards). + Experience working in a regulated environment. This includes knowledge of, and experience with, applicable standards, GxP requirements, and regulations. + Experience managing projects and demonstrating project leadership abilities **You will be responsible for:** + Collaborate with design and engineering teams to integrate quality requirements into the design process. + Develop and document quality plans, risk management files, and validation/verification protocols for new products. + Conduct design reviews to ensure compliance with quality standards and regulatory requirements. + Perform risk assessments using tools such as Failure Mode and Effects Analysis (FMEA) and Design Verification and Validation (DVV). + Analyze and interpret data to identify trends and opportunities for product improvements. + Create, interpret and implement sampling plans. + Participate in the development of product specifications and testing protocols. + Ensure that all design documentation meets quality standards and is properly maintained. + Support regulatory audits and inspections, providing necessary documentation and evidence of compliance. + Implement corrective and preventive actions (CAPA) in response to quality issues identified during the design process. + Train and mentor cross-functional teams on quality standards and best practices in design quality. **Qualifications** : + A Bachelor’s Degree is required in engineering, science, or related technical field + A total of 3-5 years of work experience in a regulated industry (medical device or pharmaceutical) + Proven experience in quality engineering, preferably in design quality or product development. + Strong understanding of quality management systems (QMS) and standards, such as ISO 13485, or FDA regulations. + Proficiency in design verification and validation methodologies. + Excellent analytical skills and problem-solving abilities. + Demonstrating a high level of proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements. + Strong communication skills and the ability to work collaboratively in a team environment. **Location** : Preferable Nijmegen, the Netherlands. Other EMEA locations may be considered. Remote work options may also be considered on a case-by-case basis and if approved by the Company.