Quality Assurance Engineer

Compunnel

United States

United States

Über

Job Description: Part of the Process Validation Group, focusing on validation deliverables within reagent manufacturing Collaborate with senior QA staff and report to Senior Manager, Process Validation Responsible for Process Validation Reagents and related quality activities Write and execute IOQ (Installation & Operational Qualification) and spreadsheet validations Perform PQ (Performance Qualification), TMV (Test Method Validation), and AQ (Analytical Qualification) validations Develop, maintain, monitor, and audit Quality Management Systems (QMS) and protocols Ensure compliance with regulatory standards, systems automation, and process procedures Support continuous improvement of validation processes and documentation Requirements: Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, Bioengineering, or related field) 5+ years of experience in the medical device industry Familiarity with CFR 21 Part 820 and ISO 13485 regulations Strong proficiency in Microsoft Excel and working knowledge of computer programming/systems Preferred Qualifications: Experience with PQ, TMV, AQ, and NPSV validations Exposure to GAMP5 or similar regulatory frameworks ASQ Certified Quality Engineer (CQE) certification

United States

Sprachkenntnisse

English

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