Belvidere, New Jersey, United States
I bring expertise in building and improving Quality Management Systems, with a special talent for process validation and statistics. My 20 years of experience is multi-disciplinary, enabling me to bridge gaps across internal stakeholders and with external partners in order to achieve mutual objectives. Specific skills include: • People Leadership and Mentorship • Process Validation • Test Method Validation • Software QA and Validation • Design Verification and Validation • CAPA Root Cause and Effectiveness Check • Process Improvement • Statistical Data Analysis How I Add Value... I am known as an analytical problem solver and people leader who assists organizations in maximizing quality and reducing costs: • Streamline the Quality Management System using technology, work flow studies, and thoughtful business analytics. • Deep knowledge of statistical sampling plans and analysis. • Experience in training teams on all aspects of validation. • Excellent communication skills. Professional Experience… Olympus Corporation 2024 - 2026 Senior Manager Business Development Quality Assurance Getinge Corporation 2019 – 2024 Director, Process Validation and Statistical Techniques Stryker Orthopaedics 2006 – 2019 Senior Staff Validation Engineer – Mergers&Aquisitions Director, Quality Assurance – Orthobiologics Senior Manager, North America Shared Services