What are the responsibilities and job description for the Quality Assurance Specialist position at Swoon?
Swoon partners with a global leader in medical device manufacturing to find a skilled Quality Assurance Analyst for their Skaneateles, NY office. This hybrid position, with the option for remote work for the right candidate, is a one-year contract with high potential for extension or conversion based on performance.
This role involves investigating and analyzing quality engineering complaints, identifying systemic issues, and driving corrective actions. Your expertise in FDA regulations, statistical analysis, and quality systems will play a key role in ensuring product safety and compliance.
Key Responsibilities:
- Investigate and analyze quality engineering complaints
- Identify systemic issues and drive corrective actions
- 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
Qualifications:
- 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
