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WELCOME!

Thank you for your interest in my problem-solving skills

Let's face it, medical device manufacturing has distinct challenges such as: 

Changing regulatory environments ...
Accelerated product development cycles ...
Increasing competition ...
New reimbursement regimes ...
Risk management ...
483s ...
CAPAs ...
... just to name a few ...

As a seasoned professional with extensive experience at multinational medical device corporations, I understand these challenges well.

PROBLEM-SOLVING METHODS

Here are some of the problem-solving methods in which I have expertise:

  • CAPA: Corrective and Preventive Action
  • DMAIC: Define, Measure, Analyze, Improve, and Control
  • FMEA: Failure Modes and Effects Analysis
  • SPC: Statistical Process Control
  • Pareto Analysis
  • Kaizen
  • Poka-yoke
  • Fishbone Diagram (Cause and Effect/Ishikawa diagram)
  • Process Capability Study 
  • Gap Analysis
  • Gage R&R Analysis
  • 5 Whys 
  • Failure analysis

KEY PROFESSIONAL SKILLS

  • Quality Management Systems (QMS)
  • Current Good Manufacturing Practices (cGMPs)
  • Medical device regulations and standards
  • Critical thinking
  • Multitasking in a fast-paced environment
  • Working well under pressure 
  • Excellent written and verbal communication skills

EDUCATION AND CERTIFICATES

I have a Master of Science in Electrical Engineering (MSEE) from the Kaunas University of Technology. I am also a certified ISO Lead Auditor by BSI, and I have performed many internal and external audits.

While working at multinational medical device corporations, I took numerous non-degree courses. I also received extensive mandatory training on policies and procedures at each corporation.

RESUME AND REFERENCES 

My resume and references are available upon request. Please visit the Recommendations  page on my LinkedIn site to read testimonials and recommendations from my colleagues.

WHAT YOU CAN EXPECT 

I will quickly assimilate into your environment and expediently begin work. Rest assured that I will complete all assigned tasks on time, and my work will be fully compliant with applicable medical device standards, regulations, and company policies and procedures. I have a proven ability to quickly grasp complex issues and understand sophisticated technologies. Companies appreciate the fact that I am a reliable team player who gets things done with minimal supervision.

I live in Florida, so I most likely will not be within commuting distance of your facility. If you choose to retain my services, I will stay in a hotel near your facility for the duration of the project.

INTERESTED?

If you need help in resolving your pressing problems, you can reach me at contact.