Senior Quality Engineer - Validation at SAP

Department: Quality

Compensation

$0/yr

Setup: Hybrid
Location: Dublin
Type: Full-time
Level: senior
Posted: Sep 18, 2026

Summary from listing

West is hiring an NPI Quality Manager to support new-product-introduction projects with FDA QSR, cGMP, ISO 13485, validation, metrology, risk management, quality-systems, customer, supplier, and audit activities. The role reports to the NPI Senior Quality Manager or Quality Work Package Manager, requires a third-level qualification in Engineering, Quality, or Science, at least five years of high-volume manufacturing experience, and is hybrid with onsite work three days per week. No relocation is provided.

Required Skills

FDA QSR
ISO 13485
Medical device validation
SPC
Minitab
Risk management
FMEA
QFD
Auditing

Additional Information

Minimum Education: Third-level qualification in Engineering, Quality, or Science
Required Previous Experiences: At least 5 years of experience in a high-volume manufacturing environment, ideally in the medical device or pharmaceutical sector
Preferred Qualifications: Knowledge of ISO 13485 and 21 CFR Part 820
Knowledge of 21 CFR Part 210 and 211
Plastic process manufacturing, computer validation, analytical methods, testing, and documentation systems
Auditing experience under ISO 13485 and 21 CFR Part 820