Job Title: Design Quality Assurance Specialist
This is an exciting opportunity to contribute your expertise and passion for quality assurance in a dynamic and collaborative environment where your ideas and contributions will be valued and respected.
* You will be responsible for ensuring product quality, safety and effectiveness as a lead Quality Engineer on projects.
* Ensuring project teams are utilizing Medical Quality Systems and appropriate regulations and industry standards throughout the product development process.
* Conducting risk assessments of the design to determine ability to function as intended.
* Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
* Interacting with customer and supplier companies in a professional manner; proactively communicating with them to ensure an ongoing two-way exchange of information.
* Intervening and contributing to successful resolution of technical issues when they arise.
The ideal candidate will have a minimum Bachelor's degree in Engineering or related field and 3 years of medical device design and development/quality assurance experience.
They must also possess excellent communication skills, both written and verbal, and be able to interact with client companies in a professional manner.