- Reference: 43723
- Job Type: Permanent
- Location: Offaly, Westmeath
- Category: Production
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
- Provide Risk management expertise, guidance and supervision during project phases.
- Development and maintenance to risk management files to support new and existing products (Including – Risk Management Plans, MDHA’s, AFMEA, DFMEA, PFMEA, Risk Benefits Analyses, Post Market Surveillance plans).
- Use knowledge of statistics to assist with the development of Risk assessments and FMEA documentation.
- Work with team on product transfers from product development to manufacturing.
- Support Engineering, Regulatory and Manufacturing in Risk management activities as required.
- Support other Integra Manufacturing sites (Toll Sites) in the area of Risk Management
- Assisting with CAPA investigations.
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Hons Degree in Engineering, Quality Engineering or a related technical discipline.
- A minimum of 2 years experience of working within a Medical device or other regulated industry with knowledge of Risk Management (ISO 14971), MDD (Medical Device Directive), ISO 13485 (Quality Management Systems), FDA and cGMP.
- Strong analytical skills and problem solving techniques
- Familiar with electronic medical devices manufacturing is an advantage.
- Familiarity with the requirements of validating product and processes.
- Working knowledge of statistical analysis.
- Equipment and Process Validation experience desirable
- Excellent communication and skills – written, oral and PC.