Steve Worcester

About Steve Worcester

Degreed engineer experienced in quality management systems and regulatory compliance in highly regulated environments (Medical Device and Nuclear industries). Experience includes all phases of the product lifecycle including design controls, manufacturing, distribution and post-market surveillance (incl complaint handling). Particular strength in FDA compliant and ISO certified Quality Management Systems. Detailed knowledge of FDA and international regulations/ISO Standards and EU Directives having performed numerous compliance audits to same. Consistently recognized for his business astuteness and ability to manage the natural polarity of Quality and Production and is expert at improving quality processes to align both business needs and regulatory constraints. Conscientious, results-oriented manager, adept at handling numerous diverse tasks simultaneously, and with experience in a broad spectrum of engineering driven and highly regulated industries.

Experience

1. Advisor to Chief Executive Officer

   Zmi Pharma

   Sep 2024 — Present

Education

• Purdue University

  BS, Mechanical/Nuclear Engineering

  1968 — 1971

• Purdue University

  Bachelor of Science - BS, Nuclear Engineering

• Bettis Atomic Power Laboratory

  Post Graduate Certificate, Nuclear Reactor Engineering

  1972 — 1972

Skills

• Regulatory Affairs
• Manufacturing
• Cross-Functional Team Leadership
• Iso 14971
• Glp
• 21 Cfr Part 11
• Qsr
• Gmp
• Product Development
• Quality Assurance
• Quality Management
• Six Sigma
• Quality Auditing
• Medical Devices
• Capa
• Process Improvement
• Dmaic
• Lean Manufacturing
• Validation
• Iso 13485
• Design Control
• Quality System
• Quality Systems
• V&V
• Iso
• Fda