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Quality Engineer

Company: Actalent
Location: Oceanside
Posted on: March 17, 2023

Job Description:

For immediate consideration, please apply directly to this job posting AND email with the following:

  • WORD copy of updated resume
  • 4-5 bullet points highlighting your qualifications for the roleDescription:--- Adheres with the company's Quality Management System to ensure compliance with applicable regulatory requirements. --- Equipment, Process, and Software, verification, and validation, including an understanding of test tools and methods, test documentation, test management, test traceability, defect management and tracking --- Assist with Risk Management efforts --- Troubleshoot and drive efficiency, cost savings and continuous process and quality improvements through application of six sigma, 5S, and lean manufacturing --- Provides statistical support to analyze processes and to recommend appropriate process controls for ensuring product conformance to specification --- Provide subject matter expertise for related, NCMRs, CAPAs, and complaintsSkills:FDA, ISO 9001, ISO 13485, spc, qms, doeAdditional Skills & Qualifications:--- Bachelor's degree from four-year College or university in Engineering or computer science--- 3 minimum years of experience required. --- ASQ CQE (Certified Quality Engineer), ASQ CQA (Certified Quality Auditor) preferred--- Understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016) --- Understanding of IEC 62304 requirements --- Working knowledge of SPC, DOE, probability, and statistics --- Prior successful testing and validation of manufacturing processes in a machining environment --- Know FDA and ISO requirements, how to conduct thorough validations. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Oceanside , Quality Engineer, Engineering , Oceanside, California

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