Contract position: Large medical device manufacturer has a need for Sr Quality Engineer in Round Lake IL to lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and quality systems. This is a contract position expected to last 12 months, could be longer based on performance, possible temp to hire. Great Contractor Benefits! Apply Now! Will hire ASAP! Responsibilities for the Quality Engineer
Requirements for the Quality Engineer
- Ensure compliance with global quality systems and Regulatory requirements related to product and process Design Control, risk analysis, investigations, and CAPAs
- Support the sustainability and life cycle management of an existing product
- Perform design change control activities including impact assessments, reviews, and approvals
- Provide Quality Assurance support and guidance for verification and validation of product requirements
- Support risk management activities as they relate to post market surveillance
- Use statistical trending tools to monitor product complaint trends
- Bachelor's degree in Engineering or Science
- 4-8 years' recent relevant experience in the medical device industry.
- Previous experience working with Electromechanical IV pumps or syringe pumps, preferred.
- Experience in design control and strong knowledge of DHF and configuration management
- Software: Excel (pivot tables, v-lookups)*, Minitab*, Word, PowerPoint, Trackwise 8 (change control / compliant), & TCU
- Product development experience pertaining to electromechanical devices 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.