
Senior Design Quality Assurance Specialist
2 weeks ago
Role Summary:
We are seeking an accomplished Design Quality Assurance professional to lead our balloon catheter product family projects.
Key Responsibilities:- Lead projects and ensure compliance with design changes and regulatory requirements
- Provide coaching and mentoring support to a team of engineers
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams
- Maintain an effective quality system and resolve PIRs, CAPAs, NCEPs, and regulatory requirement changes
Required Skills and Qualifications:
- NFQ Level 8 qualification in a STEM discipline
- Minimum of 6 years of industry experience in Design Assurance
- Experience in design control, risk management, design change, and standards compliance to regulatory requirements
- Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills
Benefits and Opportunities:
- Competitive salary
- Professional development opportunities
- Dynamic work environment
We are based in Galway, Ireland, and are looking for experienced professionals to join our organization.
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