Haidy Henes

Sr Product Quality Manager @West Pharmaceutical Services

Scottsdale, AZ, US
EMAILS
h••••••••@westpharma.com
MOBILE NUMBERS
+16•••••••50

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WORK HISTORY

Jul 2024 — Present

Sr Product Quality Manager @West Pharmaceutical Services

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EDUCATION

2003 — 2008

Arizona State University

Biomedical Engineering

SKILLS

Corrective and Preventive Action (Capa)Microsoft WordMedical DevicesCapaFdaIso 13485Microsoft OfficeCqaU.s. Food and Drug Administration (Fda)Quality SystemV&VBiomedical EngineeringCustomer ServiceQuality AssuranceCross-Functional Team LeadershipIso 14971Design ControlValidationDesign of ExperimentsPowerpointMicrosoft Excel

ABOUT HAIDY HENES

I have over 10 years of experience as a Quality Engineer with a demonstrated work history in the medical device industry. I am skilled in the U.S. Food and Drug Administration (FDA) guidelines for medical devices, ISO 13485, 14971, TrackWise, Complaint handling, Change Control, DMAIC Six Sigma, Process work flow, risk management/analysis, root cause analysis (RCA), technical writing, Sustaining Engineering, Corrective and Preventative Action (CAPA), data analysis, supplier CAPAs, SCARs, Non-conformances, verbal and written communication, supplier controls, process qualification and process verification and validation (V&V). Additionally, I am working with cross functional departments and between multiple Bard sites to identify and minimize bottlenecks in processes, implementing process improvements, and reducing overall backorder by 40% resulting in increased revenue by $1M.

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