Senior Quality Analyst

Talascend is currently seeking a Senior Quality Analyst for a contract opportunity with our client in Madison, Wisconsin .


Overview
The Senior Quality Analyst/Engineer is responsible for ensuring the effectiveness of quality activities, processes, and products related to CAPA, change management, investigations, deviations, and quality reviews at the Madison facility. This role involves quality system improvements, data analysis, trending, and collaboration across various departments to promote a quality-driven culture.
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
• Lead Good Documentation Practice training and coordinate quality activities on the floor
• Interpret and apply all applicable regulatory requirements
• Coordinate and support facility audits by internal and external entities
• Manage data collection and reporting for product recalls when necessary
• Perform trending of quality systems to support FDA and management reviews
• Enhance quality culture through site initiatives and improve procedures to meet regulatory standards
• Review and approve procedures, protocols, reports, and related documentation

Qualifications

• Bachelor's degree or higher in a science or technology field (preferred)
• 5+ years of quality assurance experience in a cGMP environment, with medical devices experience preferred
• Effective communication, coaching, mentoring, and presentation skills
• Ability to manage change and work independently
• Strong decision-making capabilities and project management skills
• Leadership skills and emotional intelligence
• Proficiency in using statistics for trending and data interpretation
• Proficiency with Microsoft Office tools, particularly Excel, Word, and PowerPoint
• Technical writing skills
• Experience with statistical analysis software such as Minitab (preferred)
• Demonstrated ability to perform the duties of this position through relevant experience, training, or education.

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.


Background Check and Drug Screen may be required.