Talentburst · Miami, FL
📢 Hiring: Principal Quality Assurance Engineer – Process Validation 📍 Location: Miami, FL 📅 Duration: 12-month contract 📧 Recruiter: adam.smith@talentburst.com ☎️ Direct: (508) 628-0000 TalentBurst is recruiting a Principal Quality Assurance Engineer for a direct client. This position is part of the Process Validation Group and supports validation activities for reagents within a regulated manufacturing environment. Key responsibilities: - Author and execute IOQ and spreadsheet validations - Complete PQ, TMV, and AQ validation activities - Develop, maintain, monitor, and audit quality-management systems and protocols - Support automated systems, manufacturing processes, and controlled procedures - Ensure validation activities comply with applicable regulations and standards - Collaborate with senior QA personnel and the Process Validation team Required qualifications: - Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical/Bioengineering, or a related engineering discipline - At least five years of medical-device industry experience - Working knowledge of FDA 21 CFR Part 820 and ISO 13485 - Proficiency with Microsoft Excel - Working knowledge of computer programming and computerized systems Preferred qualifications: - Experience with PQ, TMV, AQ, or NPSV validations - Familiarity with GAMP 5 or similar regulatory guidance - ASQ Certified Quality Engineer certification Interested candidates should send an updated résumé in Microsoft Word format, along with their contact information and availability, to: 📧 adam.smith@talentburst.com ☎️ (508) 628-0000 Hiring QualityAssurance ProcessValidation ValidationEngineer MedicalDevices ISO13485 FDACompliance GAMP5 CQE TMV QualityEngineering MiamiJobs ContractJobs
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