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.