Pete Sparacio

About Pete Sparacio

Global Quality Management and Regulatory Compliance executive with a successful track record in healthcare (Medical Devices, Pharmaceuticals), telecommunications, electronics and consumer products industries. Process-driven, strategic and customer focused leader who implements solutions that create high performance results aligned with business objectives. Principled professional able to effectively partner with individuals and teams at all levels of the organization. Specialties include: Product/Process Quality Improvement (HQ\'s/Domestic & International Mfg. Facilities) Lean/Six Sigma (ASQ Certified Six-Sigma Black Belt) Total Quality Management (TQM) Process Validation Regulatory Affairs/Compliance FDA, International Regulatory Agency Interaction & Audits Quality Systems Design & Quality Engineering Sterilization Technology (EtO, Radiation) Contract Manufacturing Risk Management ISO 13485/TL Medical Device & Pharmaceutical Regulations (i.e. QSR) Quality Auditing Business Excellence Methodologies Supplier Quality Management Statistical Methods Laboratory Operations

Experience

1. Head of Global Quality Assurance & Regulatory Affairs

   AMETEK

   Jan 2022 — Present

Education

• Keller Graduate School of Management of DeVry University

  MBA, Marketing

• Northern Illinois University

  BS, Biology

Skills

• Iso 13485
• Quality Management
• Design Control
• Quality Assurance
• Quality System
• Six Sigma
• Medical Devices
• Capa
• Gmp
• Process Improvement
• Validation
• Regulatory Affairs
• Contract Manufacturing
• Business Process Improvement
• Fda
• Strategic Planning
• Cross-Functional Team Leadership