Quality Engineer

  • location: Round Lake, IL
  • type: Contract
  • salary: $40 - $50 per hour
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job description

Quality Engineer

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
  • 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
Requirements for the Quality Engineer

  • 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
Benefits

  • Paid Vacation
  • 401K
  • 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.

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