Design Quality Engineer

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

Job Description:

Are you ready to take on a unique and exciting opportunity as a 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 Design Quality Engineer you will work on the development, implementation, and maintenance of quality assurance processes within the design and development phases of products. You will collaborate with cross-functional teams to identify and resolve issues, ensuring compliance with industry standards and regulations.

In this position you will work on the 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 growing proficiency in applying various tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions as well as process and business improvements.

• Demonstrates growing proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes, and effects analysis).

• Contributes to the reliability assessments of product design

• Contributes to root cause investigations using various problem-solving techniques and tools and assesses the effectiveness of corrective actions.

• Supports the development of test methods in equipment, process, and product qualifications/validations. Executing methods as needed for development and qualification.

• Implements and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).

• Supports execution of project plans as a contributing member of the team.

• Communicates business related issues or opportunities to next management level.

You will be responsible for:

• Develop and implement quality assurance processes for design projects.

• Conduct design reviews and risk assessments to identify potential quality issues.

• Collaborate with design engineers to ensure designs meet quality requirements.

• Analyze data and feedback to drive improvements in design processes.

• Participate in the development of product specifications and testing protocols.

• Create, interpret and implement sampling plans.

• Facilitate root cause analysis and corrective action for design-related problems.

• Prepare and present quality reports to stakeholders.

• Support regulatory audits and inspections, providing necessary documentation and evidence of compliance.

• Performs other duties assigned as needed

Qualifications

• A Bachelor’s Degree is required in engineering, science, or related technical field

• Proven experience in quality engineering or related role.

• Strong understanding of quality assurance methodologies and tools.

• Excellent problem-solving skills and attention to detail.

• Knowledge of quality management systems (QMS) and standards, such as ISO 13485, or FDA regulations

• Strong communication and teamwork skills.

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.