Lead Validation Engineer – Medical Devices & NPD

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%)

Relocation Budget

Paid Annual Leave

Job summary

Independent Search Solutions Ltd is seeking a Validation Supervisor to lead a site-based Quality Engineering team in County Mayo. You will plan, coordinate and execute validation activities for automated equipment to support NPD, changes and strategic initiatives.

The role requires 8–12 years in medical device QA, CQE or equivalent, and strong knowledge of ISO 13485 and FDA parts. Competitive compensation, relocation support and annual bonus are offered.

Qualifications

• 8–12 years quality engineering experience in medical device industry.
• Certified Quality Engineer (CQE) or equivalent.
• Experience with ISO 13485 and FDA 21 CFR Parts 820 and 11.

Responsibilities

• Lead Quality Engineering Team (6 direct reports).
• Support New Product Development, Change Control and Feasibility Projects.
• Mentor QEs through projects and ensure timelines are met.

Skills

Quality Engineering

Leadership

Validation

Statistical Analysis

CAPA

Education

Third level qualification in Science/Engineering

CQE certification

Tools

SPC

ISO/Regulatory Familiarity

Job description

Independent Search Solutions Ltd is seeking a Validation Supervisor to lead a site-based Quality Engineering team in County Mayo. You will plan, coordinate and execute validation activities for automated equipment to support NPD, changes and strategic initiatives.

The role requires 8–12 years in medical device QA, CQE or equivalent, and strong knowledge of ISO 13485 and FDA parts. Competitive compensation, relocation support and annual bonus are offered.