Senior Quality Engineer, Orthopedics - MedTech Innovator

Johnson & Johnson Co.; Ireland; On-site; EUR 53,000 - 84,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson in Ringaskiddy, Cork is seeking a Senior Quality Engineer - Orthopedics. You will lead quality engineering activities across the product lifecycle, ensuring compliance with QSRs, ISO 13485, and regulatory standards.

The role involves risk management, CAPA handling, design transfer support, and collaboration with R&D and manufacturing to drive continuous improvement. Candidates should have a bachelor’s degree in engineering, 4–6 years’ experience in FDA/European regulated

Qualifications

• Bachelor’s degree in Engineering or related field and 4–6 years of related experience.
• Experience in FDA and European regulatory environments is preferred.
• Strong knowledge of GMP/ISO quality systems and risk management.
• Hands-on problem solving and leadership capabilities.

Responsibilities

• Lead quality engineering activities across the product lifecycle.
• Apply Quality Engineering tools to improve product/process capability.
• Support design transfer and new product introductions with robust risk assessments.
• Conduct investigations, CAPAs and root-cause analyses to prevent reoccurrence.
• Collaborate with R&D, Manufacturing and Supply Chain to ensure compliance and continuous improvement.

Skills

Quality engineering

Risk management

Statistical analysis

Lean Six Sigma

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

Statistics software

SPC

DoE

Job description

Johnson & Johnson in Ringaskiddy, Cork is seeking a Senior Quality Engineer - Orthopedics. You will lead quality engineering activities across the product lifecycle, ensuring compliance with QSRs, ISO 13485, and regulatory standards.

The role involves risk management, CAPA handling, design transfer support, and collaboration with R&D and manufacturing to drive continuous improvement. Candidates should have a bachelor’s degree in engineering, 4–6 years’ experience in FDA/European regulated