Senior Design Assurance Quality Engineer I
HERO Recruitment
| Company | HERO Recruitment |
| Category | Engineering |
| Location | Mayo, Ireland |
| Remote | — |
| Employment | Not stated |
| Level | Senior |
| Salary | Not stated by the employer |
| First seen | 2 Aug 2026 (the employer did not state a posting date) |
| Last verified | 10 Aug 2026 |
| Source | The employer's own careers page (company_site) |
Description
Location: Mayo Department: Quality
Position Summary: This role provides Design Control Quality Engineering services for Continence products at the Ballina manufacturing facility, supporting the growth and operational excellence of the business.
Key Responsibilities:
• Serve as a core team member on Continence NPI (New Product Introduction) projects representing the Quality function.
• Facilitate Design Controls, Risk Assessments, and DFMEA activities.
• Support specification and drawing development, PFMEA, and Process Validation for NPI projects.
• Conduct ISO 13485, FDA, and QSR internal audits according to the annual schedule.
• Assist with CAPA analysis and problem-solving for NPI projects and manufacturing processes.
• Perform statistical analysis to support quality initiatives.
• Deliver personnel training in relevant Quality practices.
Work Experience:
• 5–8 years’ experience in the Medical Device Industry.
Education & Qualifications:
• Degree in Engineering or Science discipline.
• Quality Engineering qualification or ASQ CQE certification.
• Proven experience with Design Controls and NPI projects.
• Experience in statistical analysis and process validation.