Medical Device Validation Engineer

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

Job summary

Sanmina Fermoy seeks a Validation Quality Engineer to join the Quality Department. The role focuses on developing and executing validation plans for medical devices in a GMP-regulated setting, including process and software validation across Fermoy operations.

The ideal candidate has a QQI Level 7 degree in a relevant field and at least 2 years in QA/regulatory roles, with strong knowledge of GMP and CDRH guidance. Collaboration with cross-functional teams is essential.

Qualifications

• QQI Level 7 Degree in a relevant science/engineering field.
• Minimum of 2 years Quality Assurance / Regulatory affairs experience.
• Experience performing Process Validation per CDRH Guidance.
• Familiarity with GAMP 4 or GAMP 5 software V&V techniques.
• Strong problem solving and analytical skills.
• Proficient in MS Word, Excel and PowerPoint; able to draft SOPs and regulatory responses.
• Experience with statistical analysis, DOE and DMAIC methods.

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.
• Resolution of problems encountered during validation.
• Ensure consistency in validation/qualification approaches across systems and projects.
• Provide guidance in preparation and execution of validation activities.
• Remain up-to-date with GMP requirements for site-wide regulatory compliance.
• Maintain the Validation system including periodic reviews.
• Participate in change control processes for manufacturing and facility changes.
• Ensure ongoing regulatory compliance and health & safety regulations.

Skills

Quality Assurance

Regulatory affairs

Process Validation

GAMP 4/5

Problem Solving

Statistics / DOE / DMAIC

MS Word

Excel

PowerPoint

Education

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

Six Sigma Green or Black Belt

Tools

GAMP 4/5 Software V&V Techniques

Job description

Sanmina Fermoy seeks a Validation Quality Engineer to join the Quality Department. The role focuses on developing and executing validation plans for medical devices in a GMP-regulated setting, including process and software validation across Fermoy operations.

The ideal candidate has a QQI Level 7 degree in a relevant field and at least 2 years in QA/regulatory roles, with strong knowledge of GMP and CDRH guidance. Collaboration with cross-functional teams is essential.