Randy Koester

About Randy Koester

I hold a steadfast belief that no challenge is insurmountable when one harnesses the collective strength of a team, fosters partnerships, and maintains a positive attitude. This belief is the core of my leadership style and guides my approach in all endeavors. Prioritizing people, I emphasize the importance of building trusted relationships and nurturing an inclusive environment where every voice is both heard and valued. Through empowerment, I enable individuals to evolve into leaders who support and respect one another, fostering success in their roles and nurturing continuous professional growth.I possess a proven track record as a change agent, driving organizational and process transformations that have consistently contributed to business growth. Through adept leadership, I have guided teams in developing and implementing scalable, streamlined processes, adhering to industry standards and regulations while benchmarking best practices across medical device, IVD, and pharmaceutical sectors. My extensive background encompasses international and multi-site management, lean principles, compliance remediation, and effective supplier oversight. Furthermore, I excel in preparing and hosting regulatory inspections, including FDA, A2LA, and Notified Body assessments.Key Competencies:• Strategic Planning & Execution• Organizational Design & Development• External Audit Management• Inspection Preparedness• Global Quality Management System Implementation / Harmonization / Remediation• Supplier Quality Management• Recall Management• Failure Investigation & Root Cause Analysis• Validation• CAPA / Complaints• EtO and Gamma Sterilization Controls• Clean Room Controls• ISO Standards ISO 13485, ISO 9001, ISO/IEC-17025, ISO/IEC-17043, ISO 14971, ISO 14644• FDA Regulations 21 CFR parts 820, 210, 211, & 4Contact me @r••••••••@gmail.com or (+17•••••••59.

Experience

1. Vice President Quality and Regulatory

   Paragonix Technologies, Inc

   Nov 2023 — Present · Waltham, MA, US

Education

• University at Buffalo

  BACHELOR OF SCIENCE, Chemical Engineering

  1991 — 1995

Skills

• Dmaic
• Iso 13485
• Quality Management
• Design Control
• Minitab
• Quality Assurance
• Quality System
• V&V
• Six Sigma
• Quality Auditing
• Spc
• Medical Devices
• Capa
• Quality Control
• Gmp
• Process Improvement
• Lean Manufacturing
• Fda Gmp
• R&D
• Validation
• Regulatory Affairs
• Root Cause Analysis
• Iso
• Pharmaceutical Industry
• Business Process Improvement
• Fda
• Manufacturing
• Cross-Functional Team Leadership
• Iso 14971