GREG SEBASTIAN

• CAPA Board Chair ensures CAPA program is managed effectively and that all users are coached ensuring proper investigation analysis is conducted, risk analysis is performed, action plans are created, and effectiveness is measured. Serves as primary approver for all CAPAs for the organization.
• Responsible for implementing One QMS transformation projects. This includes leading Trackwise CAPA system rollout within the local organization, collaborating with multiple groups to ensure system readiness and software testing.
• Responsible for monthly reporting for KPIs, quality metrics, process analysis monitoring.
• Lead Hispanic Latino Network supporting three pillars for culture, professional development, and community. Lead six co-chairs ensuring quarterly activities were available for employees.
• Served on Steering Committee for Live Well Kosciusko implementing "Clock Into Potential" program.

• Drove corrective and preventive actions at leadership level to accomplish project closure and recurrence control, providing necessary resources and clearing roadblocks for team
• Collaborated with developers and subject matter experts to assess program capabilities, features and testing demands for VEI Atlas Vac Integration Project
• Teamed on design reviews for ability to produce and inspect product. Reviewed issues and opportunities during product planning and stages for multiple projects.
• Developed team communications and information for sterile services, packaging, and CAPA meetings
• Saved over $62,000 by implementing LIP COS set-screw cell that supported cost-saving initiatives for FY19
• Saved over $60,000 by implementing ROTO project which supported plant cost savings initiatives for FY19
• Acted as Microbiologist for a eighteen months supporting all activities needed within Warsaw Medtronic site
• Outlined work plans, determined resources, wrote timelines as part of project scope determination for implementation of Material Usage Tracker project for all sterile and non-sterile packaging areas as well for Differential Pressure Sensor Upgrade project
• Facilitated process improvements for finishing area resulting in 41.5% decreased NCMRs within single year

• Executed CAPA root cause analysis to improve yield and reliability
• Responsible for all packaging components and processes related to quality systems
• Complete supplier quality activities including non-conformance disposition, manufacturing transfers, criteria creation, maintenance of criteria, first article approval and validation review / approvals
• Process Improvement activities related to overall inspection cost reduction and inspection improvement
• Collaborate with Spine Headquarters for procedure clarity updates
• Project manager for various improvement projects and manufacturing transfers
• Coordinated with quality control staff to complete inspections

• Applied statistical analysis techniques and skill in Minitab to complete GR&R and Statistical Analysis
• Evaluated results against design standards and compliance requirements for NPD to create individual Test Methods for each feature on new product prints
• Other Responsibilities included Equipment Qualification, Root Cause Analysis, Change Control Creation and Completion, First Article Creation, Creating CMA (Component Material Assessment) Forms and Journals, Creation of Inspection Reports (q-sheets)

• Responsibilities included PDM approvals (supporting injection molding department), CAPA (Corrective and Preventative Action), Value Improvement Projects, and Development of Certification training materials, orientation development, orientation implementation, training systems, best practices for training new hires, and "on the job" training practices
• Supported multiple plant wide teams including Master Brand Initiative, Factory of the Future, Print 1 Seal 1, Manufacturing Electronic System team, Shop Floor Paperwork training, Label certification/recertification training

Assembled products within four different areas.