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.