Validation Supervisor - Medical Devices

Independent Search Solutions Ltd; Connacht; On-site; EUR 70,000 - 80,000; Full time

Benefits offered by this job

Health Insurance

Pension (4%/8%)

Annual Bonus (10%)

Life Assurance (x4)

Relocation Budget

Paid Annual Leave

Job summary

Independent Search Solutions Ltd. in Mayo is seeking a Validation Supervisor to lead a site-based team of Quality Engineers and oversee validation for automated equipment. The role supports New Product Introduction, change control, and strategic quality initiatives.

Requirements include 8-12 years in medical device quality engineering, CQE or equivalent, and strong ISO/FDA regulatory knowledge, with SPC experience. Relocation assistance is provided.

Qualifications

• 8-12 years of quality engineering experience in the medical device industry.
• CQE or equivalent professional certification.
• Strong knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11.
• Experience in statistical analysis/SPC and validated automated equipment.

Responsibilities

• Lead a quality engineering team of 6 direct reports.
• Support New Product Development, Change Control and feasibility projects.
• Mentor engineers to meet project timelines.
• Plan resources and timelines for validation activities with engineering.
• Lead quality improvements with Quality Manager.
• Complete internal audits per schedule and support CAPA.

Skills

Quality Engineering

Leadership

New Product Development

Regulatory Knowledge

Automated Equipment Validation

Education

Third Level Qualification in Science/Engineering

Job description

Independent Search Solutions Ltd. in Mayo is seeking a Validation Supervisor to lead a site-based team of Quality Engineers and oversee validation for automated equipment. The role supports New Product Introduction, change control, and strategic quality initiatives.

Requirements include 8-12 years in medical device quality engineering, CQE or equivalent, and strong ISO/FDA regulatory knowledge, with SPC experience. Relocation assistance is provided.