Summary: Are you looking to bring your skill-set to a new quality engineering role? Are you interested in being part of a medical device company spear heading the industry in minimally invasive surgery? My client is looking to add a quality engineer that will maintain the quality system and support outgoing quality product to support production, design and development their products. My client creates laparoscopic and electrosurgial instruments that allow highly complex procedures to have fewer complications, lower costs and better patient outcomes. Does this sound like something you would be interested in learning more about? Please see the below!
The Quality Engineer will be responsible for:
- Assisting in design and development of new products.
- Approving engineering change orders.
- Working with failure mode effect analysis, root-cause and 5-why.
- Maintaining quality records and performing corrective actions and non-conformance assessments.
- Performing internal and supplier audits.
- Participating and leading continuous improvement projects.
The Quality Engineer should have the following requirements:
- Bachelor's Degree in Engineering or equivalent experience.
- At least 5 years of engineering experience, preferably in the medical device industry.
- Worked with FDA 21CFR820 and ISO13485.
- Preferred experience with aseptic production and/or sterilization.
- Lean and Six Sigma knowledge is a plus.
If this sounds like something that you would be a good fit for, please do not hesitate to apply!