Mary Nikish

Quality Engineer @Bruker

Bremen, DE
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2018 — Present

Quality Engineer @Bruker

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Responsible for review and approval of design control documentation from a quality perspective for IVD & RUO consumables. Participates in deign reviews and products releases- Manages/owns CAPA process and system- Manages/owns Internal Audit process and schedule. Including auditing various processes- Manages/owns Document Control Process and Training Process- Track quality trends and initiated action items to resolve issues.

EDUCATION

N/A

Stevens Institute of Technology

Bachelor of Engineering (B.E.), Biomedical/Medical Engineering

SKILLS

SolidworksValidation EngineeringStatistical Data AnalysisMatlabMicrosoft ProjectEngineeringProcess ValidationBiomedical EngineeringMinitabCorrective and Preventive Action (Capa)Verification and Validation (V&V)Iso 13485Medical DevicesSix SigmaU.s. Food and Drug Administration (Fda)Microsoft WordQuality SystemManufacturingValidation Master PlansMicrosoft ExcelFda GmpQuality AuditingCustomer ServiceMicrosoft OfficeAutocadDmaicMimicsPowerpointValidation ReportsData AnalysisLabview

ABOUT MARY NIKISH

Professional with a Bachelor of Engineering in Biomedical Engineering, from Stevens…

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Mary Nikish — Quality Engineer at Bruker in Bremen, DE | Unifers