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Senior Quality Engineer

Company: Fluxergy Inc
Location: Irvine
Posted on: January 16, 2022

Job Description:

Fluxergy is on the cutting edge of point-of-care diagnostics in both the human and veterinary spaces. You will aid us as part of the Quality team, to ensure our processes, procedures, and product meet ISO 13485 and FDA requirements. With this being an senior position, you will be expected to learn these processes quickly. However, our processes are always improving. So, quick and enthusiastic learners are desired. At Fluxergy, all employees are expected to improve the quality of our product. Because of this, you will have an active role with the Production Team to implement process improvements.ResponsibilitiesEnsure design documents are completed, approved, and meet requirementsPerform validations on equipment, software and processesDevelop risk management plans and reportsPerform internal audits and supplier auditsSupport Purchasing on managing and qualifying new suppliersSupport external and customer auditsDeveloping and implementing quality standards. and processesMonitoring and analyzing quality performance.Collaborating with operations managers to develop and implement controls and improvements.Ensuring that workflows, processes, and products comply with safety and regulatory regulations.Investigating and troubleshooting product or production issues.Developing corrective actions, solutions, and improvements.Reviewing codes, specifications, and processes.Perform other duties as assigned to support business needs3+ years of experience in quality engineering, quality assurance, or a similar role.3+ years working with medical device industry with ISO 13485Strong knowledge of Microsoft Office ApplicationsStrong analytical and problem-solving skillsExcellent verbal and written communication skillsAble to work efficiently in a team environmentExperience coding and using QA software tools and processes.Excellent project management skills.Experience3+ years of experience in quality engineering, quality assurance, or a similar role.2+ years in a manufacturing environment2+ years in medical device industryExperience with ISO 13485 and FDA is a plusEducationDegree in quality, biology, or engineeringASQ certification preferred.

Keywords: Fluxergy Inc, Irvine , Senior Quality Engineer, Engineering , Irvine, California

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