Michael Visocnik

About Michael Visocnik

Michael Visocnik has been engaged in engineering, operations, quality, & reliability for…

Experience

1. Director, Quality - Global Complaint Management Post Market Surveillance

   ICU Medical

   Oct 2019 — Present

   Develop and maintain ICU Medical’s global Post Market Surveillance and Customer Advocacy strategy and vision ensuring adherence with evolving global regulatory requirements and customer expectations. Manage a team of managers, individual contributors, and vendors who are responsible for performing Post Market Surveillance activities. This includes activities such as complaint processing, complaint investigations, regulatory reporting, post market plans/summaries, trending, customer advocacy, and customer communications. Responsible for keeping top management current of the most salient trends in process and product performance and identify regulatory risks. Provide post-marketing complaint data for a broad base of stakeholders doing analysis of data for risk management, investigations and regulatory interaction (audits, inquiries, recertifications). Provide on-site support to regulatory audits.

Skills

• Part 820
• Quality Assurance
• Plant Maintenance
• Maintenance & Repair
• Operations Management
• Rcm
• Process Engineering
• Engineering
• Strategy
• Planned Preventative Maintenance
• Cmms
• Fmea
• Maximo
• Iso 14971
• Six Sigma
• Predictive Maintenance
• Business Process Improvement
• 5s
• Total Productive Maintenance (Tpm)
• Preventive Maintenance
• Reliability
• Continuous Improvement
• Benchmarking
• Manufacturing
• Oee
• Reliability Engineering
• Value Stream Mapping
• Maintenance Management
• Project Management
• Kaizen
• Iso Standards
• Operational Excellence
• Process Improvement
• Lean Manufacturing
• Iso
• Root Cause Analysis
• Iso 13485
• Tpm
• Dmaic
• Change Management