Alec Alpert
Quality Engineer/Consultant ▪️ Indpendent Business Owner at Alpert Engineering, LLC | Greater Tampa Bay Area
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Alec Alpert, as the founder and lead consultant of Alpert Engineering, LLC, brings over three decades of specialized expertise in quality engineering and regulatory compliance within the medical device industry. Currently serving as a Quality Engineer and Consultant, Alec plays a pivotal role in guiding medical device companies through complex regulatory landscapes, ensuring their products meet stringent standards such as 21 CFR 820, ISO 13485, ISO 14971, and EU MDR. His deep understanding of design control processes, risk management, and validation engineering enables clients to develop safe, reliable, and compliant medical devices from concept through production.
At Alpert Engineering, Alec spearheads key projects involving design verification and validation, test method validation, and process validation master plans, ensuring that all phases of product development adhere to industry best practices and regulatory requirements. His expertise in technical documentation, supplier management, and reliability assurance helps streamline manufacturing processes, reduce risk, and enhance product quality. Alec’s hands-on approach includes developing validation protocols, managing MRB (Material Review Board) activities, and supporting production teams with test fixture design and troubleshooting.
Moreover, Alec’s proficiency in regulatory submissions and compliance audits ensures that clients are well-prepared for inspections and certification processes. His strategic guidance in risk management and process improvement not only mitigates potential compliance issues but also fosters a culture of continuous quality improvement. Whether assisting startups or established manufacturers, Alec’s comprehensive knowledge and practical experience make him a trusted partner in delivering safe, effective, and compliant medical devices that meet global standards.
Quality Engineer/Consultant ▪️ Indpendent Business Owner at Alpert Engineering, LLC in November 2011 to Present
Risk Management Engineer/Consultant at Cook Medical in August 2018 to June 2020
Quality Engineer/Consultant at Endologix, Inc. in April 2018 to July 2018
CAPA Engineer/Consultant at Zimmer Biomet in November 2016 to February 2018
Systems Engineer/Consultant at Medtronic in June 2016 to October 2016
Quality Engineer/Consultant at Philips in November 2014 to March 2016
Quaity Engineer/Consultant at Abbott in March 2012 to November 2014
Regulatory Compliance Consultant at Medtronic in November 2011 to February 2012
Senior Quality Engineer at GE Healthcare in July 2009 to October 2011
Senior Quality Engineer at Terumo Medical Corporation in September 2007 to July 2009
Senior Quality Engineer at BD in March 1995 to August 2007
Senior Quality Engineer at Draeger Medical in January 1989 to March 1995
Senior Manufacturing Engineer at GE Aviation in March 1980 to January 1989
Senior Field Service Engineer at Siemens Healthcare in February 1976 to April 1980
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Kaunas University of Technology, Master’s Degree, August 1970 to August 1975
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Process Validation
Design Assurance
Risk Management
Root Cause Analysis
FMEA
Failure Analysis
CAPA
Technical Documentation
DMAIC
Regulatory Compliance
Manufacturing Support
Failure Mode and Effects Analysis (FMEA)
Medical Devices
U.S. Food and Drug Administration (FDA)
Systems Engineering
Customer Support
Cross-functional Team Leadership
Test Method Validation
Gage R&R
21 CFR 820
ISO 14971
Reliability Assurance
Supplier Management
Quality System Auditing
Design Transfer
Incoming Inspection
Complaint Investigations
MRB
Printed Circuit Boards
Design Control
Medical Device Directive
Part 820
Ncmr
Mdrs
Post Market Surveillance
Design Verification Testing
Test Fixtures
Test Procedures
Procedures Documentation
Compliance Procedures
Process Verification
Product Transfer
Validation Master Plans
Consent Decree
Deviations
Validation Reports
Validation Engineering
Capas
Test Validation
New Product Validation
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What is Alec Alpert email address?
Email Alec Alpert at [email protected] and [email protected]. This email is the most updated Alec Alpert's email found in 2026.
What is Alec Alpert phone number?
Alec Alpert phone number is 1-443-824-4659.
How to contact Alec Alpert?
To contact Alec Alpert send an email to [email protected] or [email protected]. If you want to call Alec Alpert try calling on 1-443-824-4659. (updated on May 18, 2025)
What company does Alec Alpert work for?
Alec Alpert works for Alpert Engineering, LLC
What is Alec Alpert's role at Alpert Engineering, LLC?
Alec Alpert is Quality Engineer/Consultant ▪️ Indpendent Business Owner
What industry does Alec Alpert work in?
Alec Alpert works in the Medical Devices industry.
Alec Alpert Email Addresses
Alec Alpert Phone Numbers
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