QA Engineer II – (Sterile Procedure Tray) SPT Waukegan


Medline Industries, Inc. has an immediate opening for a QA Engineer II for the Sterile Procedure Tray (SPT) Division. The position will be located at our Waukegan facility. We are seeking hard-working professional with excellent interpersonal skills and background in quality and medical devices, along with a desire to work for a fast-paced, large organization. In addition to exceptional leadership and analytical skills, you must have a roll-up your sleeves attitude. Responsibilities include: * 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. Requirements include: * Bachelor Degree in Engineering (Mechanical or Biomedical Engineering preferred) or related engineering field required. Master degree preferred * At least 2 years of related experience in the quality or engineering area. * Experience with medical devices preferred. * Competent understanding of ISO 13485, 21 CFR 820, and 21 CFR 820.30 preferred. * 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 (10%-20%) * Ability to work unsupervised * Self-starter and motivated

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