Job Overview
The primary objective of this position is to oversee the creation and maintenance of Design History Files/Device Master Records. This involves collaborating with the quality team to ensure that all necessary documentation is accurately prepared and up-to-date.
In addition, you will be responsible for evaluating the biocompatibility of materials used in product design, as well as identifying appropriate methods of sterilization. Your expertise in risk assessment will enable you to identify potential issues early on in the design cycle, thereby preventing costly delays or rework further down the line.
Key Responsibilities:
* Lead Quality Representative on projects by establishing comprehensive Design History File/Device Master Record documentation.
* Evaluate material biocompatibility during product design cycle using evidence-based methodologies.
* Conduct thorough risk assessments at various stages throughout the development process
About Us
We value innovative thinking and a collaborative approach when it comes to meeting our clients' needs.
The role offers opportunities for career advancement within a rapidly growing organization where talent and dedication are recognized and rewarded..