Role and Responsibilities
The Senior Quality Engineer independently executes individual projects and leads cross-functional teams to implement larger projects. This role provides guidance and technical decision-making to the Quality Engineering personnel regarding cGMP compliance, regulatory issues, investigation strategies, process improvement initiatives, and quality systems for projects and/or strategic activities. This role supports the Quality Engineering Leader’s direction for the organization.

• Authoring, reviewing, and approving deviations, investigations, and CAPAs. Acting as Subject Matter Expert on Root Cause Analysis tools. Providing guidance on setting realistic timelines for these deviation management system documents, as well as organized updates and effectiveness check strategies.
• Identifying, owning, and implementing process improvements. Ensuring timely completion of deliverables, regular status communication, proper training to hand over to process owners, and team recognition for successful completion.
• Preparing, reviewing, and approving Change Controls. Coordinate company-wide to ensure change is well challenged, effectively implemented, and thoroughly closed.
• Reviewing and approving validation and qualification activities (protocols, final reports) to support company, equipment, product and/or performance processes.
• Executing, providing guidance, and overseeing department-wide Quality Systems, metrics and reporting, for example Customer Complaint Response & Evaluation, Quality Metric and KPI administration & presentation, and similar.
• Supporting job interviews, motivation, coaching, and training in coordination with the Quality Engineering Leader.
• Providing a professional, dynamic, cooperative, and high-achieving work environment for the staff.
• Supporting Quality Engineering Leadership by coaching other QEs in skills related to technical skills, management and leadership.
• Supporting day-to-day activities Quality response to production issues, for example, assessing Visual Inspection defects, supporting complex GDP corrections, evaluating raised issues to determine if a deviation is required, etc.