We are looking to hire a reliable Quality Engineer to join our fast-paced team at MyKelly in Wheeling, IL.
Growing your career as a Full Time Quality Engineer is a great opportunity to develop fundamental skills.
If you are strong in adaptability, cooperation and have the right work ethic for the job, then apply for the position of Quality Engineer at MyKelly today!
Quality Engineer
Kelly® Engineering is seeking a Quality Engineer for a direct hire position with a medical device client in Wheeling, IL. Our client is hiring for all levels of talent from 3-10+ years medical device quality experience. If you are passionate about shaping the world we live in and are ready to reengineer your future, trust the experts at hiring experts. Overview
This client partners with pharma companies to make infusion pumps, prefilled syringes, autoinjectors, and other types of medicine dosing products. They do product development from pre-market regulatory work through verification & validation testing as well as product lifecycle management from remediation to post-market regulatory work. Our client is hiring all levels of talent from 1-7 years of experience in medical device quality experience. Salary Range Depending on experience: $75,000-100,000
In this role you'll have 2 main responsibilities, product quality and lab activities. You will work with product development and testing to determine product quality standards. You will execute product quality testing, validation, equipment qualification, and ensure equipment calibration is up to date.
Responsibilities: Work with product development to review specifications and develop control plans, risk assessments, protocols and design history documentation. Help determine and complete deliverables. Review protocols and reports for test method validation, design verification/validation testing. Ensure controls plans capture risks. Ensure compliance with ISO 14971, ISO 13485 and 21CFR820. Support internal & external ISO audits. Analyze documentation, surveillance data, and execute control plans accordingly. Equipment qualification Calibrate instruments or schedule required calibration as well as maintain calibration records. Qualifications: Bachelors degree in engineering or science is required. 1-10 years medical device quality experience is required. DFMEA or product quality experience a plus. Working knowledge of ISO 13485 is required, ISO 14971 a plus Working knowledge FDA regulations & documentation for medical device manufacturer is required Application/interpretation of 21 CFR 820 is a plus. Internal or external auditing experience preferred. Knowledge of equipment calibration or qualification preferred. What happens next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.
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Benefits of working as a Quality Engineer in Wheeling, IL:
? Unlimited Growth Potential
? Company offers career progression opportunities
? Leading Industry Pay
