Well-established and reputable in the Medical Device space
Clear path for career growth
About Our Client
Our client is a global leading provider of IV's and IV related products to healthcare organizations around the world. They are located in a Northern suburb of Chicago.
The Quality Engineer will:
- Implement quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPAs, etc. to ensure product quality.
- Assure conformance with FDA and other international agency regulations.
- Work wit cross-functional teams throughout the organizations to implement and optimize processes.
- Participate in design reviews, test/inspection readiness reviews, risk assessments, design transfers, etc.
- Other duties as necessary.
The Successful Applicant
- BS in an Engineering discipline; Master's preferred
- 3-5 years of experience in a Quality Engineer position in Medical Device
- In depth knowledge of Quality Management Systems, Design Controls, CAPAs, Complaint Handling, Document Control, etc.
- Strong familiarity with ISO 13485 and ISO 14971 required
- ASQ CQE certification or eligible to obtain within 1 year preferred
- Knowledge of FDA and EU MDR standards preferred
What's on Offer
- Competitive base salary (based on previous experience)
- Comprehensive benefits package including health/vision/dental