Medical Device Validation Engineer - Quality & Compliance

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

Job summary

Sanmina Fermoy in Ireland is seeking a Validation Quality Engineer to formulate and execute validation plans for medical devices in a GMP/ISO13485 environment. You will own validation activities, including process and software validation, for Fermoy operations.

The role requires QQI Level 7 degree and at least 2 years QA/regulatory experience, proficiency with DOE, DMAIC, and GAMP methods, and strong MS Office skills.

Qualifications

• Typical requirements include a QQI Level 7 Degree in Science, Electronics, Mechanical or Industrial Engineering.
• Experience in QA/regulatory affairs for medical devices (2+ years).
• Experience conducting process validation per regulatory guidance (CDRH).
• Proficiency with GAMP methodologies and statistical analysis (DOE/DMAIC).
• Proficient with MS Word, PowerPoint and Excel; ability to write SOPs and regulatory responses.

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 and ensure consistency across systems.

Skills

Process Validation

GAMP 4/5

MS Office

DOE & DMAIC

Regulatory compliance

Education

QQI Level 7 Degree in Science/Engineering

Tools

GAMP 4/5

MS Word/PowerPoint/Excel

Job description

Sanmina Fermoy in Ireland is seeking a Validation Quality Engineer to formulate and execute validation plans for medical devices in a GMP/ISO13485 environment. You will own validation activities, including process and software validation, for Fermoy operations.

The role requires QQI Level 7 degree and at least 2 years QA/regulatory experience, proficiency with DOE, DMAIC, and GAMP methods, and strong MS Office skills.