Are you a passionate Senior Quality Engineer looking for an exciting new opportunity to work with a leading medical device company in Ballina? Look no further! We are seeking an experienced Senior Quality Engineer to join our Client on a permanent, full-time basis. This role offers the successful candidate opportunities for growth and advancement within the company.
Responsibilities | Detailed Job Description Available on Request
As a Senior Quality Engineer, your duties will include:
- Developing and implementing Master Validation Plans, Risk Assessments, and leading QE activities in the Value Stream.
- Developing and completing DV/IQ/OQ/PQ protocols.
- Contributing to the development of FAT/SAT protocols.
- Executing Validation Protocols, root cause deviations, and generating validation reports.
- Developing product specifications, drawings, and quality plans in conjunction with NPD personnel.
- Providing QE support for New Product Development (NPD) projects.
- Conducting Process Risk Management/FMEA.
- Completing internal audits per the audit schedule.
- Coordinating and implementing process capability analysis on catheter processes.
- Completing CAPA investigations.
- Leading Hollister Production System (HPS) audits for the department.
- Supervising Quality Engineers and Associate Quality Engineers during project activities.
Requirements
As a Senior Quality Engineer, you will need to have:
- A Bachelor's degree in Engineering/Science Discipline and Quality Engineering Qualification.
- 6+ years of experience in the Medical Device Industry utilizing automated equipment.
- Experience in statistical analysis/SPC/validation of automated equipment.
- Experience in people management.
If this Senior Quality Engineer role interests you, please contact Emma Cawley today.