Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Risk Analysis Specialist
The Risk Analysis Specialist will report to the Engineering Manager.
This is a permanent role based in The Midlands with excellent progression opportunities.
Key Responsibilities of Risk Analysis Specialist:
- 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 client Manufacturing sites (Toll Sites) in the area of Risk Management
- Assisting with CAPA investigations.
- 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
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.