Quality Engineer, Medical Devices | Data-Driven QC

Johnson Johnson; Cork; On-site; EUR 55,000 - 96,000; Full time

Job summary

Johnson & Johnson, DePuy Synthes, is seeking a Quality Engineer for a 12-month contract to support quality engineering activities across the product lifecycle. You will apply Lean, Six Sigma, and risk management methodologies to improve processes and ensure compliance with global regulatory standards.

The role collaborates with R&D, Global Supply Chain and manufacturing teams to execute IQ/OQ/PQ, CAPA and process validation while maintaining GMP/ISO compliance.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 2-4 years of relevant experience in quality engineering.
• Experience in FDA and European regulatory environments preferred.

Responsibilities

• Support Continuous Improvement using Lean, Six Sigma, Kaizen and PDCA.
• Collect data and perform statistical analyses to drive process improvements.
• Ensure compliance with ISO 13485, FDA, MDR and corporate quality guidelines.
• Lead CAPA activities and non-conformance investigations with root-cause analysis.
• Collaborate with R&D, Global Supply Chain and manufacturing teams on process validation and control.

Skills

Quality engineering

Lean Six Sigma

Statistical analysis

Problem solving

Education

Bachelor's degree in Engineering

Tools

MSA

SPC

DOE

Reliability

Job description

Johnson & Johnson, DePuy Synthes, is seeking a Quality Engineer for a 12-month contract to support quality engineering activities across the product lifecycle. You will apply Lean, Six Sigma, and risk management methodologies to improve processes and ensure compliance with global regulatory standards.

The role collaborates with R&D, Global Supply Chain and manufacturing teams to execute IQ/OQ/PQ, CAPA and process validation while maintaining GMP/ISO compliance.