Senior Quality Analyst/Engineer

About the role

The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the Madison facility. This position will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and direct involvement and collaboration with the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality 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
• 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

Requirements

• 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)
• Effective communication, coaching/mentoring, and presenting skills
• Ability to manage change
• Self-motivated
• Independent and sound decision making capabilities
• Project management to deliver on time results
• Leadership skills / Emotional Intelligence
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data

Skills

• Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint
• Technical writing
• Organizational Relationship/Scope
• Statistical analysis
• Minitab or other software equivalent, preferred

Working Conditions

The Senior Quality Analyst will mainly work in an office environment. Domestic and international travel will be required on a limited basis. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is onsite during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support business needs.