Steve Redlin

About Steve Redlin

Innovative, self-motivated, decision maker with over 20 years’ experience in the Quality, Operational, Compliance, Project Management and Technical aspects of the medical device industry and supply base. A strategic thinker with strong multi-tasking and troubleshooting skills with the ability to identify and manage risk, adapt, prioritize, and thrive in a global, dynamic and matrixed environment. A champion of collaborating with all aspects of the business to ensure a world class culture of performance while driving to meet and exceed the goals of the Business. Continuously seeking improvement opportunities to meet changing regulatory and business requirements to ensure the ability to meet the needs of the business, customer and regulators. Proven background in management of both personnel and global projects.

Experience

1. President

   Neocoil

   Jun 2020 — Present

Education

• University of Wisconsin-Parkside

  Bachelor of Science (B.S.), Biology/Biological Sciences, General; Minor: Chemistry

  1989 — 1993

Skills

• Minitab
• 21 Cfr Part 11
• Dmaic
• Regulatory Submissions
• Quality Assurance
• Iso Standards
• Change Control
• Asq
• Sterilization
• Regulatory Affairs
• Medical Device Directive
• Cqa
• Compliance
• 21 Cfr
• Quality Management
• Quality Control
• Gmp
• Quality System
• V&V
• Root Cause Analysis
• Fda Gmp
• Lims
• Complaint Management
• Computer System Validation
• Supplier Quality Management
• Fmea
• Validation
• Supplier Quality
• Iso 14971
• Regulatory Requirements
• Trackwise
• Management Review
• Quality System Compliance
• Ce Marking
• 5s
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Gamp
• Iso
• Glp