Senior Quality Contractor
Karen joined iDE8 in November 2021 as a Senior Quality Engineer, coming from the medical device industry gaining experience across all aspects of Quality - Design, Operational, Supplier and Post market Launch.
With her wealth of knowledge on clinical operations, research and development, product management, Quality Lab Services and Products Lifecycles - Karen provides all aspects of quality support including CAPA's (Corrective Action Plans), NC's and Field Actions.
Karen is also an experienced Lead Auditor in both internal and supplier audits - giving her international experience throughout ISO13485:2016.
"What I love about working at iDE8 is how every one of us take pride in what we do and how dedicated we are to our clients. Each person brings a unique perspective to the table, enabling us to better serve each client.
As an individual, I love learning new things, hearing different perspectives, and broadening my horizons; being an auditor gives me that opportunity every day."
ISO13485 Lead Auditor, Quality Systems, Supplier Quality, Industrial Statistics
Document Control Services
Whether you need a few updates or an entire overhaul of your Quality systems, we can do it all - from managing change requests to reference checking and everything in between.
Our document control team is a natural extension of your Quality department - after all, you know we care about every little detail just as much as you do.