Design Quality Engineer (m/f/d)

Description:

Johnson & Johnson is currently seeking a Design Quality Engineer (m/f/d) to join our Abiomed Team located in Aachen, Germany.

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/.

The Design Quality Engineer supports design iterations of products through the entire Product Lifecycle. These activities include leading Risk Management assessments, collaborating with development teams to establish appropriate testing plans, guide teams through Design Controls, ensure compliance to the Quality Management System.

Key Responsibilities:

The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

• Drive quality focused design and development within the product’s development lifecycle by defining requirements, verification and validation plans and strategies while maintaining traceability
• Lead and conduct risk management activities (FMEAs)
• Ensure that design controls are compliant to internal procedures as well as applicable external standards and norms
• Support regulatory bodies submission of new products
• Participate in design reviews
• Review and approve design documentation
• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA etc.), ISO 13485, ISO 14971, MDR and other national and international quality and regulatory requirements and standards
• Support escalations and conduct technical investigations
• Leading multidisciplinary projects and processes
  
  

Qualifications:

Qualifications:

Education:

• At minimum bachelor’s degree in engineering or sciences is required
  
  

Experience and Skills:

• Knowledge of ISO 13485 and ISO 14971, experience in the medical device industry is an advantage
• Demonstrated knowledge of statistical analysis tools (Minitab etc.)
• Knowledge of SAP and/or other MES Systems is preferred
• Significant teamwork and leadership skills
• Quality-oriented and attention to details is required
• Good communication skills, both verbal and written in English and German