Senior Quality Engineer - Orthopedics, Ringaskiddy

Biopharma Asia; Cork; Hybrid; EUR 53,000 - 84,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson is seeking a Senior Quality Engineer for the Orthopedics group at the Ringaskiddy Cork site. You will drive quality improvements across product lifecycle, ensuring compliance with international standards and leading CAPA investigations.

The role emphasizes risk management, process validation, and collaboration with cross-functional teams to deliver safe, effective orthopedic solutions. Competitive base pay and comprehensive benefits are provided.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• Experience in FDA/European regulatory environments is preferred.
• Strong knowledge of GMP/ISO regulations and validation concepts.
• Proven leadership in quality engineering and project management.

Responsibilities

• Lead quality improvement initiatives to drive process and product enhancements.
• Ensure compliance with QSRs, ISO 13485 and applicable regulations; support audits.
• Manage non-conformances, CAPAs and customer complaints with effective root-cause analysis.
• Develop and implement control plans, risk management and design transfer for new products.
• Collaborate with R&D, manufacturing and supply chain to ensure CTQs are addressed.

Skills

Quality planning

Regulatory compliance

Risk management

CAPA management

Lean Six Sigma

Process validation

Communication

Education

Bachelor's degree in Engineering

Job description

Johnson & Johnson is seeking a Senior Quality Engineer for the Orthopedics group at the Ringaskiddy Cork site. You will drive quality improvements across product lifecycle, ensuring compliance with international standards and leading CAPA investigations.

The role emphasizes risk management, process validation, and collaboration with cross-functional teams to deliver safe, effective orthopedic solutions. Competitive base pay and comprehensive benefits are provided.