Are you looking for an experienced quality engineer to help you with design verification, risk management, resolution of CAPAs, process validation, remediation of audit findings … or perhaps other aspects of quality assurance and regulatory compliance?

My name is Alec Alpert and I am the quality assurance engineer and consultant with over 30 years of experience helping medical device companies ensure product quality and regulatory compliance.

Over the course of my career, I have worked with major corporations, including:

Philips Healthcare, St. Jude Medical, Medtronic, GE Healthcare, Terumo Medical, Becton Dickinson, Draeger Medical, GE Aviation Systems, and Siemens Healthcare.
What kind of assignments do I handle?
I cover the full spectrum. About 80 percent of my assignments are:

Other assignments include:

► Resolution of customer complaints.
► Quality systems auditing (ISO, FDA).
► Incoming inspection.
► Documentation/technical writing.
► Design transfer to manufacturing.
► Failure analysis.
► Reliability assurance.
What you can expect:

When you work with me, you can rest assured that the assigned tasks will be completed on time with full compliance to medical device standards, regulations and procedures. I am able to quickly grasp complex issues and understand sophisticated technologies. Companies appreciate the fact that I can work well with scientists, engineers, software developers, technicians, marketing professionals, and other specialists, ask the right questions and get things done.

To see how I can help you, view my Specialties and About.

Then, give me a call at 443-824-4659 (U.S. Eastern Time Zone).