Validation Engineer Supervisor

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

My client has a requirement for a Validation Supervisor for their facility in County Mayo.

You will need to have 8-12 Years Quality Engineering experience in the Medical Device Industry utilizing Automated Equipment.

Your responsibilities will involve leading the Quality Team (6) and supporting New Product Introductions.

A Full Time / Permanent role, we are offering a Relocation Budget for successful candidates who require moving to County Mayo –

Validation Supervisor / Quality Engineer Lead / Validation Engineer / Automated Equipment / Medical Device / Leadership / Mayo / Ireland

Job Title: Validation Supervisor

Direct Reports: (6)

Location: County Mayo

Package:

• Full Time / Permanent
• €70k - €80k+ Basic (Dependent on Experience & Open to Negotiation)
• Annual Bonus (10%)
• Health Insurance
• Pension (4%/8%)
• Paid Annual Leave
• Life Assurance (x4)
• Relocation Budget (€)

Role:

The Validation Supervisor leads a site-based team of Validation Quality Engineers and is accountable for the effective planning, coordination, and execution of equipment and process validation activities in support of new product introductions, change control, and strategic initiatives.

Working closely with Design Assurance, Engineering, Manufacturing, and Quality teams you will ensure validation activities are executed in compliance with the Quality Management System and applicable regulatory requirements.

Stakeholders: Design Assurance, Engineering, Manufacturing, Quality Teams, Product Development, Corporate Quality Management and R&D.

Duties:

• Lead Quality Engineering Team (6 Direct Reports)
• Provide Quality Engineering support for New Product Development, Change Control and Feasibility Projects
• Mentor QEs through projects and ensure completion of projects per timelines
• Plan resources and timelines for validation lifecycle activities to support NPD / change control projects etc. in collaboration with engineering
• Lead quality improvements in conjunction with Quality Manager
• Complete Internal audits per the audit schedule
• Support CAPA system

Experience:

• Third Level Qualification in Science, Engineering, or related discipline
• 8-12 Years Quality Engineering experience in Medical Device Industry
• Certified Quality Engineer (CQE) or equivalent professional certification
• Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 and 11, and related regulatory standards
• Experience in Statistical Analysis / SPC / Validation of Automated Equipment

Key Words: Validation Supervisor / Quality Engineer Lead / Validation Engineer / Automated Equipment / Medical Device / Leadership / Mayo / Ireland