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QA Engineer

Company: SNI Technology
Location: Crystal Lake
Posted on: January 15, 2022

Job Description:

Quality Engineer Location: Algonquin, moving to Schaumburg in March. Salary: $80-90K This role assumes primary responsibility for ensuring the QMS is aligned with the requirements of 21 CFR 820, ISO 13485, EU MDR, and other applicable regulations and standards. MAJOR RESPONSIBILITIES:Develop and implement procedures for process controls, process improvement and process validation to ensure effectiveness and compliance.Monitor key and critical processes.Apply statistical process control methods for analyzing data to evaluate the current processes and process changes.Lead investigation of product and process non-conformances and collaborate with suppliers and internal teams to ensure implementation of effective corrective actions.Lead supplier evaluation and monitoring process.Participate in internal and external audits and lead the process for responding to the audit findings.Additional duties as assigned by the Director of Quality and ComplianceEducationBachelor's or higher degree in Engineering, Science, Math or related technical field.Knowledge / Skills / AbilitiesExcellent verbal and written communication skillsStrong multi-tasking and project management skillsExperience with accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.Experience using time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.Working knowledge of 21 CFR 820, ISO 14971, and ISO 13485.At least 3 years of industry experience in Medical Devices, Drugs, or other related fields.Proficient in using MS Office Suite products (Word, Excel, PowerPoint, Outlook).Please submit resumes to bhayes@snitechnology.com

Keywords: SNI Technology, Crystal Lake , QA Engineer, Engineering , Crystal Lake, Illinois

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