Ty P.

About Ty P.

Quality Assurance Specialist with a proven track record in risk mitigation, and process optimization across healthcare, medical devices, and education sectors. Over the past seven years, I’ve specialized in building systems that ensure accuracy, audit readiness, and regulatory alignment. In my current role, I apply a detail-driven approach to testing and quality control, ensuring products and processes meet the highest standards of integrity and performance.My expertise spans QA methodologies, regulatory compliance, health information systems (Epic), and operational efficiency. I thrive in environments where precision and purpose intersect — whether it’s improving workflows or driving continuous improvement initiatives. MDR (21 CFR 803), 21 CFR 820, ISO 13485, audit support, Track Wise these are premium signals vs. general QA Core Strengths: Quality Assurance • Test Planning & Execution • Risk Mitigation • Regulatory Compliance • Process Improvement • Data Accuracy • Audit Readiness • Cross-Functional Collaboration

Experience

1. Quality Systems & Compliance Specialist

   Früh Verpackungstechnik Ag

   Dec 2025 — Present

   Maintain and strengthen the Quality Management System (QMS) to ensure compliance with ISO 13485 and FDA 21 CFR 820 requirements, contributing to improved audit readiness and higher QMS maturity.Manage the full document control lifecycle for SOPs, work instructions, and quality records, ensuring 100% version control, timely approvals, and proper archival to support internal, customer, supplier, and regulatory audits.Support complaint handling, deviation management, and root‑cause analysis (RCA), ensuring corrective actions are well‑documented, implemented on time, and compliant with regulatory and internal requirements.Participate in internal audits and assist with preparation for external, supplier, and customer audits by organizing objective evidence, CAPA documentation, and corrective action responses.Support supplier qualification and incoming material inspections to verify conformance to quality, safety, and performance specifications.Assist with process, equipment, and validation activities, including Sterilization Validation (IQ/OQ/PQ review, load configuration assessment, and validation documentation), ensuring protocol adherence and fully compliant validation records.Perform and support Test Method Validation (TMV) activities to ensure inspection and analytical methods are accurate, repeatable, and aligned with regulatory expectations.Lead continuous improvement initiatives, including full 5S deployment across sterile and non‑sterile warehouse areas, resulting in improved workflow efficiency, reduced retrieval errors, and enhanced audit transparency.Serve as Training Coordinator, managing training matrices, updating training materials, and maintaining 100% on‑time completion of required employee training across all departments.

Education

• Eastern University

  Master of Business Administration - MBA, Organizational Leadership

• Cheyney University of Pennsylvania

  Bachelor of Arts - BA, Criminal Justice and Corrections

Skills

• Social Media
• Research
• Powerpoint
• Microsoft Excel
• Microsoft Word
• Strategic Planning
• Microsoft Office
• Sales
• Public Speaking
• Leadership
• Management
• Customer Service
• Project Management
• Training
• Marketing