Medical Device Validation Engineer (Contract, 6-12 Months)

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

Job summary

Sanmina Fermoy in Fermoy, Ireland, seeks a Validation Quality Engineer (6–12 month contract) to lead validation activities for medical devices in a GMP-regulated environment. The role covers process and software validation, ensuring regulatory compliance and change control across projects.

The ideal candidate has a QQI Level 7 degree and at least 2 years in QA/regulatory affairs, with GAMP 4/5 experience, strong documentation, and statistical skills. Background in medical devices is preferred.

Qualifications

• QQI Level 7 Degree in Science, Electronics, Mechanical or Industrial Engineering.
• Minimum 2 years Quality Assurance / Regulatory affairs experience.
• Experience in completing Process Validation’s as per CDRH Guidance.
• Experience in using Gamp 4 or Gamp 5 Software Validation.
• Sound understanding and utilization of Problem Solving Techniques.
• Proficient in MS Word, PowerPoint and Excel.
• Ability to respond to inquiries from internal customers and regulatory agencies.
• Ability to write SOPs, training documents, regulatory responses.
• Technically competent.
• Experience in statistical Analysis / DOE and DMAIC methods.
• Experience in Medical Device Manufacturing Environment is desirable.
• Six Sigma Green or Black Belt Certified is desirable.
• Experience of electronic production processes is desirable.

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 approach across systems and projects.
• Provide guidance and direction in the preparation and execution of validation activities.
• Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
• Maintain Validation system including conducting Periodic Reviews.
• Participate in change control processes for manufacturing process and facility modifications.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Ensure compliance with Health & Safety Legislation and Regulations.

Skills

Quality Assurance

Regulatory affairs

Process Validation

Software Validation

GAMP 4/5

Problem Solving

MS Word

PowerPoint

Excel

Documentation

Statistical Analysis

DOE

DMAIC

Six Sigma

Medical device manufacturing

Electronic production

Education

QQI Level 7 Degree

Job description

Sanmina Fermoy in Fermoy, Ireland, seeks a Validation Quality Engineer (6–12 month contract) to lead validation activities for medical devices in a GMP-regulated environment. The role covers process and software validation, ensuring regulatory compliance and change control across projects.

The ideal candidate has a QQI Level 7 degree and at least 2 years in QA/regulatory affairs, with GAMP 4/5 experience, strong documentation, and statistical skills. Background in medical devices is preferred.