What are the responsibilities and job description for the Medical Device Compliance Expert position at Swoon?
We are seeking a highly skilled Quality Assurance Analyst to join our team at Swoon's Skaneateles, NY office. As a hybrid employee, you will have the flexibility to work remotely while still being part of our dynamic and innovative environment.
This role offers a one-year contract with high potential for extension or conversion based on performance. You will be responsible for investigating and analyzing quality engineering complaints, identifying systemic issues, and driving corrective actions.
About the Role:
- Investigate quality engineering complaints and identify systemic issues
- Analyze data from various quality inputs to determine trends and systemic issues
- Develop and communicate expectations for quality performance and continuous improvement
- Monitor and drive corrective action and continuous improvement activities
Requirements:
- Bachelor of Science degree in Engineering
- 1-3 years of Medical Device experience
- Knowledge of FDA regulations and quality systems
- Statistical analysis and problem-solving skills
