Senior Design Assurance Quality Engineer I.

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.