Facility Project Engineer @ (August 2022 - April 2024)
Validation Engineer @ (June 2021 - August 2022)
Associate Validation Engineer @ (October 2019 - June 2021)
Validation Specialist @ (June 2018 - October 2019)
Biomedical Equipment Technician @ (January 2017 - June 2018)
Mechanical Laboratory Lead Technician @ (February 2014 - January 2017)
Sergi Malets Education
Bemidji State University
Applied Management (Business Administration and Management, General)
2018-2022
Anoka-Ramsey Community College
Associate of Science - AS (Biomedical Technology/Technician)
2014-2018
Sergi Malets Skills
ISO 13485
FDA GMP
EMS Management
Equipment Qualification
Technical Writing
Software Lifecycle Management
Bill of Materials (BOM) Creation
Request for Proposal (RFP)
Capital Projects
Capital Equipment
Acceptance Testing
Microsoft Project
cGMP manufacturing
Risk Assessment
Project Engineering
Change Control
Corrective and Preventive Action (CAPA)
TrackWise
Quality Management
Preventive Maintenance
Construction Management
Troubleshooting
Project Management
Protective Coatings
Medical Devices
Laboratory
Product Launch
Customer Service
Quality Control
Manufacturing
Validation
Biomedical Engineering
Process Improvement
Root Cause Analysis
Product Development
Continuous Improvement
Design of Experiments
Research and Development (R&D)
Cross-functional Team Leadership
Microsoft Office
Business Process Improvement
Sergi Malets Summary
Sergi Malets, based in Anoka, MN, US, is currently a Senior Manufacturing Engineer at NACS, Inc. (now part of Ascential Medical & Life Sciences). Sergi Malets brings experience from previous roles at Ferring Pharmaceuticals and Bosch USA. Sergi Malets holds a 2018 - 2022 Applied Management in Business Administration and Management, General @ Bemidji State University. With a robust skill set that includes ISO 13485, FDA GMP, EMS Management, Equipment Qualification, Technical Writing and more. Sergi Malets has 1 emails and 1 mobile phone numbers on RocketReach.
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