Matthew Berger

About Matthew Berger

Highly experienced with more than 8 years of engineering expertise dealing with complex regulatory requirements and another 10 years of medical lab expertise in a highly regulated field by such organizations as the FDA, OSHA, European Union, and other state and federal agencies. Skilled in planning, testing, development, and implementation of new process and techniques, while using varying operating systems for the successful completion of projects. Promoted best-practices and good laboratory practices (cGMP\'s) & (GLP\'s) at all times. Experienced in aspects of project management, audit management, regulatory compliance, document control, AQL batch sampling, and quality systems maintenance and control. Additional areas of responsibility in leading corrective actions, writing Standard Operating Procedures (SOP\'s) and validation of new manufacturing processes and procedures.I am a firm believer in leadership by example, hard work resulting in positive successes, succeeding as a team and when you fail as team you learn from that and become better and more successful in the future.

Experience

1. Senior Quality Engineer

   Globus Medical

   Mar 2023 — Present · West Carrollton City, OH, US

   Development of Test Protocols & Validations for complex or new processes-Coordinates and writes, Manufacturing Plans, Quality Plans, and technical papers-NPI Support, defines process & individual process needs to launch projects-CapEx - New processes/requests-Evaluates Process trends and defines countermeasures-Trains others how to manage risk through pFMEA and escalates high risk manufacturing processes into device Risk Management File-Responsible for the integration of manufacturing process with the Design History File-Lead complex CAPAsStandards & Guidance working with:ISO 9001:2015ISO 13485:2016ISO 14971:2019IEC 60812:2020

Education

• Sinclair Community College

  Associate of Arts and Sciences (A.A.S.), Biotechnology

  2015