Medline Industries, Inc. has an immediate opening for a Quality Assurance
Engineer II supporting our Namic Division located in Northfield, IL. The
product line includes but not limited to: heart kits, pressure monitoring kits,
waste management kits, and interventional radiology and Cathlab accessories. We
are seeking a hard-working professional with excellent interpersonal skills,
background in quality, along with a desire to work for a fast-paced, large
corporate organization. In addition to exceptional leadership and analytical
skills, you must have a roll-up your sleeves attitude .
* Provide product development protocol requirements for quality standards,
inspection techniques and inspection frequencies, lot sizes, statistical
analysis, sterility requirements, etc
* Lead Product Development and Design Control activities.
* Lead in Risk Analysis meetings.
* Lead project teams for CAPA activity.
* Review/Approve Process Validations (i.e. Packaging, Sterilization, etc.)
* Coordinate or perform inspections of new products or products from new
vendor at branches and factories.
* Work with quality inspection supervisors to train and oversee inspectors
in their use of control forms, procedures and correcting quality problems
* Assist in preparing reports to communicate involvement and results of
quality assurance activities
* Support all ISO and internal audits, customer requests and manage/update
industry changes as they impact quality
* Identify and implement continuous improvement initiatives
* Bachelor s degree in Engineering.
* At least 2 years of related experience in the quality or engineering
* Experience with medical devices
* Competent understanding of ISO 13485, 21 CFR 820, and 21 CFR 820.30
* Excellent written and oral communication skills
* Strong organizational, problem-solving, and analytical skills
* Ability to manage priorities and workflow
* Proficient with Microsoft Office (Word, Excel, and PowerPoint)
* Willing to travel domestic or International (25%)
* Ability to work unsupervised
* Self-starter and motivated
To apply for this job please visit itjobpro.com.