What are the responsibilities and job description for the Device Quality Compliance Expert position at Akkodis?
Akkodis is a leader in quality engineering services for the medical device industry.
We are seeking a highly skilled Medical Device Quality Complaints Analyst to join our team.
In this role, you will be responsible for investigating and resolving quality complaints related to medical devices.
You will analyze data from quality inputs, including Field Corrective Action (FCA), Complaints, and FDA Medical Device Reports (MDR), to determine trends and systemic issues.
The successful candidate will have experience with statistical software packages, such as Minitab, and knowledge of FDA regulations, including 21CFR820.
Key Responsibilities:
- Analyze data from quality inputs to determine trends and systemic issues
- Prepare and issue reports based on information analysis
- Review existing investigation reports and identify gaps for GMP compliance
- Develop strategies and plans to close gaps in an efficient and technical manner
Requirements:
- Experience with statistical software packages, such as Minitab
- Knowledge of FDA regulations, including 21CFR820
- Bachelor of Science degree in Engineering or extensive experience in complaints analysis
