Overview
Senior Quality Assurance Analyst Jobs in Madison, WI at Indotronix Avani Group
Title: Senior Quality Assurance Analyst
Company: Indotronix Avani Group
Location: Madison, WI
Job Title: Sr. Quality Analyst/Engineer
Duration: 6+ months
Location: Madison, WI 53718
Job Summary:
Principal Responsibilities:
- Develop and maintain quality system processes, including metrics reporting and tracking.
- Manage CAPA initiation, review, surveillance, and reporting.
- Facilitate the site Quality Management reviews.
- Facilitate and lead the site Change Management process.
- Support and lead root cause analyses through cross-functional team involvement.
- Leading Good Documentation Practice training and Quality on the Floor coordination and performance.
- Interpret and properly apply all applicable regulatory requirements.
- Coordinate and provide direct support for facility audits by internal and external entities.
- Manage data collection and reporting when product recalls are required.
- Perform trending of Quality Systems to support FDA and Management reviews.
- Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements.
- Review and approval of procedures, protocols, reports, etc., as required.
Minimum Requirements:
Experience / Skills:
- Bachelor’s, or higher, degree in science/technology program preferred.
- 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred).
- Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.
Competencies:
- Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint.
- Technical writing.
- Statistical analysis – Minitab or other software equivalent, preferred.
