An international company is looking for a QA/RA consultant. As a QA/RA consultant you will have the following responsibilities:
- Perform MDR gap analysis for the legal manufacturer ;
- Create required SOPs, quality agreements and other required documents to support MDR implementation ;
- Support in MDR training ;
- Support in preparation and execution of MDR audits ;
- Review and update ISO certification strategy and SOPs;
- Interact with all levels of organisation ;
- Evaluate audit responses for adequacy ;
- Resolve complex issues and escalate concerns through business and Quality Compliance Management ;
- Participate in other projects as needed.
What are they looking for in a QA/RA consultant?
- Minimum 5 year's experience in Quality, Regulatory, Compliance, Manufacturing
- Bachelor's degree in Science or Engineering discipline
- Experience in medical device
- Knowledge of EU MDD and ISO 13485
- Experience in SOP/manual/guidelines writing
- Good communication skills
- Fluent in English
The company can provide an interesting career in a dynamic environment with lots or learning and growth opportunities.
This is a job description in short, if you want more information you can send me an email or call me at 02/610.59.59.