Medical Device Validation Engineer

Sanmina; Fermoy; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sanmina Fermoy in Ireland seeks a Validation Quality Engineer to lead validation activities for medical devices. The role supports both process and software validation in a GMP-regulated environment, ensuring compliant execution and problem resolution across projects.

Essential experience includes CDRH-guided process validation, GMP practices, and proficiency with DOE/DMAIC methods. Strong problem-solving and MS Office skills are required.

Qualifications

• Qualified in science/engineering with risk-based validation experience.
• Experience in Process Validation per CDRH guidance.
• Experience in software validation in medical devices.
• Experience with GMP regulatory compliance and change control.

Responsibilities

• Own and support validation activities in a Medical Device regulated environment.
• Responsible for all Process Validation Execution in Fermoy.
• Responsible for all Software Validation Execution in Fermoy.
• Resolve problems encountered during validation.
• Ensure consistency in validation approaches across systems and projects.
• Provide guidance in preparation and execution of validation activities.
• Maintain validation systems and conduct periodic reviews.
• Participate in change control processes for manufacturing processes and facility modifications.
• Ensure ongoing compliance with quality and regulatory requirements.

Education

QQI Level 7 Degree in Science / Electronics / Mechanical / Industrial Engineering

Six sigma Green or Black Belt Certified

Statistical Analysis

DOE and DMAIC methods

Problem Solving Techniques

Tools

Gamp 4 or Gamp 5 Software V and V Techniques

MS Word

PowerPoint

Excel

Job description

Sanmina Fermoy in Ireland seeks a Validation Quality Engineer to lead validation activities for medical devices. The role supports both process and software validation in a GMP-regulated environment, ensuring compliant execution and problem resolution across projects.

Essential experience includes CDRH-guided process validation, GMP practices, and proficiency with DOE/DMAIC methods. Strong problem-solving and MS Office skills are required.