Job Title: Quality Engineer II (Design Assurance)
Galway's world-leading medical device manufacturer seeks a Quality Engineer II with strong R&D or MDR background to focus on Design Assurance.
Key Responsibilities
* Supports the approval of FDA pre-sub, FDA, and DEKRA submissions.
* Provides design quality support in resolving PIRs, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
* Understands Design Assurance requirements for marketed product, product development, design changes, technology transfers, and ensures activities comply with internal and regulatory requirements.
Requirements
* Level 8 degree in a STEM discipline.
* Minimum 2-3 years' experience in Design Assurance/Quality/R&D/Production capacity.
* Good technical capabilities, communication skills, teamwork abilities, and initiative.
Skills
* Familiarity with ISO 14971 and risk management principles.
* Collaborative mindset and ability to work in multi-functional teams.
* Excellent problem-solving and analytical skills.
About Us
Our company is a leading manufacturer of medical devices in Galway. We are committed to delivering high-quality products that meet the needs of our customers.