Quick Info
Experience Level
Mid LevelMinimum Degree
MasterDepartment
Quality Assurance ControlJob Type
Full TimeSpecialty Skills
SterilizationMicrobiologyRoot Cause AnalysisQuality SystemseQMSRisk AssessmentPFMEAProcess ControlsCAPAContinuous ImprovementMedical Device Quality Systems
About the Role
This position is for a Sr. Manufacturing Quality Engineer l with hands-on experience and proven success in managing Quality systems. The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to sterility and microbiological outputs, review and assess the accuracy and sustainability of process requirements as they pertain to sterility assurance and microbiology and drive cross-functional collaboration with quality groups across the organization. This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to eQMS, risk assessment, PFMEAs, process controls, root cause investigations, CAPA, and continuous improvement
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