Validation 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%)

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

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