Contract position: Global leader in the healthcare/medical product manufacturing industry is looking for a Quality Engineer in Round Lake IL. This is a contract position expected to last 12 months, possible temp to hire. This position will support complaint evaluations and CAPA investigations for Renal Quality Engineering activities related to medical device post-market product support for quality systems and associated disposables. Apply Now! Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Analyze quality data from various inputs (including but not limited to: nonconformance, FCA, complaints, MDR, etc) to determine trends and systemic issues
- They will prepare and issue reports based on information analysis
- Understand principles of complaint handling process, supports complaint investigations, and prepares complaint risk assessment if required
- Responsible for providing a technical review of complaints and completing an indepth assessment
- Interacts with Global Field Surveillance, plant representatives, and other cross-functional team members in complaint analysis
- Evaluations for complaints will be documented and appropriate corrective and preventative actions will be determined as part of these assessments
- BS in Engineering
- 0-2 years quality engineering experience in disposables, device, or drug renal manufacturing, will consider university experience
- Capa or complaint handling experience is preferred
- Working knowledge of 21CFR820
- Technical writing background related to product complaints and risk assessments is preferred
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.