Job Title : Design Assurance Quality Engineer
Summary : Looking for an opportunity to work with cutting edge medical devices? My client is an up and coming medical device company focusing on unmet vascular needs. Developing a groundbreaking biomaterial has differentiated their products from the traditional catheters. With 2 FDA approved products, the company is showing no signs of slowing down when it comes to getting new products on the market. If you are someone who is passionate about working with medical devices to help alleviate many clinical and economic burdens that accompany vascular access complications, this may be the job for you!
The Design Assurance Quality Engineer will be responsible for :
- Providing Quality Engineering support for product development projects throughout all phases of Design Control as well as post market surveillance activities.
- Design Assurance role on Product Development projects.
- Leading cross-functional teams to implement risk assessment and risk management processes.
- Supporting development, implementation and maintenance of Design Verification and Validation.
The Design Assurance Quality Engineer should have the following requirements :
- Bachelor's Degree in a Life Sciences or technical, preferably engineering discipline.
- At least 3 years of design assurance experience in life sciences or medical device.
- Knowledge of 21 CFR820 and ISO14971:2019
- Working knowledge of data analysis methods.
- Teamwork, flexibility and excellent written and verbal communication skills.
If this sounds like something you would be interested in, please apply!