Senior Quality Engineer, MedTech Design & Compliance

Johnson & Johnson; Galway; On-site; EUR 4,133,000 - 6,612,000; Full time

Benefits offered by this job

Competitive hourly rate

Job summary

Johnson & Johnson MedTech, specifically the Cerenovus division, is seeking a Design Quality Engineer to strengthen design control and risk management across product design and manufacturing. You will apply six sigma and lean methods, and work with R&D, Regulatory, Supply Chain, and QA to uphold the quality system and enable compliant growth.

The role involves lifecycle management, root cause analysis, vendor support, and documenting design changes.

Qualifications

• A minimum of 4 years of related experience.
• Knowledge working in a highly regulated industry.
• Familiarity with ISO 13485, specifically Design Control.
• Interpersonal skills that promote conflict resolution in both personnel and technical contexts.
• Strong written and verbal communication skills to communicate effectively at all levels.
• Excellent problem solving/root cause investigation and decision-making skills.

Responsibilities

• Responsible for ensuring Design control and Risk Management activities, wherever they are performed comply with the requirements of the quality system.
• Executes Life Cycle Management projects in a cross-functional setting as the design quality engineer core team member.
• Works on complex problems and provides solutions which are highly innovative and comprehensive.
• Applies scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
• Works independently and in cross-functional teams to determine root cause, develop mitigations and corrective and preventative actions for design, process, and manufacturing related issues.
• Utilizes the application of six sigma and lean tools and methodologies.

Skills

Communication skills

Problem solving

Teamwork

Interpersonal skills

Written communication

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Microsoft Project

FPX

Job description

Johnson & Johnson MedTech, specifically the Cerenovus division, is seeking a Design Quality Engineer to strengthen design control and risk management across product design and manufacturing. You will apply six sigma and lean methods, and work with R&D, Regulatory, Supply Chain, and QA to uphold the quality system and enable compliant growth.

The role involves lifecycle management, root cause analysis, vendor support, and documenting design changes.