Quality Engineer

Senior Quality Analyst/Engineer

The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and products related to CAPA, Change Management, investigations, deviations, Quality Management Review, audit coordination, and metrics are effectively managed for the Madison facility. The role will also support Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Roles and responsibilities include developing and maintaining quality system processes, including metrics reporting and tracking; managing CAPA initiation, review, surveillance, and reporting; facilitating site Quality Management Reviews; facilitating and leading the site Change Management process; supporting and leading root cause analyses through cross-functional team involvement; leading Good Documentation Practice training and Quality on the Floor coordination and performance; interpreting and properly applying all applicable regulatory requirements;

coordinating and providing direct support for facility audits by internal and external entities; managing data collection and reporting when product recalls are required; performing trending of Quality Systems to support FDA and Management reviews; improving quality culture through site initiatives and improving existing procedures to better align with regulatory requirements; reviewing and approving procedures, protocols, reports, etc., as required; filing and managing documentation when required;

supporting other Quality System Functions; leading personnel, inside and outside the Quality organization, in support of business needs; utilizing Microsoft Office tools, especially Excel, Word, and PowerPoint; performing technical writing; utilizing statistical analysis, including Minitab or equivalent software, for trending and interpretation of statistical data.

Education and experience requirements include a Bachelor's degree or higher in a science/technology program preferred, 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment, with medical devices preferred, effective communication, coaching/mentoring, and presentation skills, ability to manage change, self-motivated with independent and sound decision-making capabilities, project management skills to deliver on-time results, leadership skills / Emotional Intelligence, and ability to utilize statistics at a moderate level for trending and interpretation of statistical data.