Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements. Good Manufacturing Practices (GMP).
Job Responsibilities:
Assist on Coordinating and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
Assist on Coordinates purchase and delivery of Equipment/Tooling
Assist on Coordinates installation of Equipment/Tooling
Support on Developing and Executing IQ and OQ Protocols and Reports
Support on Developing and Executing Test Method Validations / Gage R&R
Support on Generating nd Issues for Approval of SOPs and Manufacturing Procedures
Support on Developing and Executing Component Qualifications
Support on Developing and Executing PQ and PPQ Protocols and Reports
Support on Developing Manufacturing Capacity Analysis
Support on Developing and Executing Process Characterizations / Design of Experiments (DOE)
Support on Developing documentation/justification for assigned capital projects
Support on Compling with cGMP's, Quality Standards , and established policies and procedures
Support on Executing other duties assigned by his Process Validation Lead & other supervisors
Qualifications Knowledge and Skills:
Bachelor's degree in engineering
Experience in the Medical Device Industries with experience in the Manufacturing Process Validation
Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels.
Qualification / Validation (IQ/OQ/PQ)
Test Method Validation / Gage R&R
Process Characterization / Design of Experiments (DOE)
OEE Integration, Vertical Start up and Zero-loss mindset
Required Education and Experience:
Requires a bachelor's degree in engineering or related field with minimum 3 years of experience in an engineering role OR MS with at least 2 year of experience in an engineering role.
Numbers & Facts
Location
El Paso, TX
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Assembly Lineunmatched
Capacity Analysisunmatched
Capital Projectunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
English Languageunmatched
Experiment Designunmatched
GMP (Good Manufacturing Practices)unmatched
ISO (International Organization for Standardization)unmatched
Machine Toolunmatched
Manufacturingunmatched
Manufacturing Analysisunmatched
Manufacturing Process Engineeringunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Molding Processesunmatched
Policy Developmentunmatched
Presentation/Verbal Skillsunmatched
Preventative Maintenanceunmatched
Procedure Developmentunmatched
Process Improvementunmatched
Process Validationunmatched
Quality Assurance Methodologyunmatched
Quality Metricsunmatched
Root Cause Analysisunmatched
SAPunmatched
Spanish Languageunmatched
Standard Operating Procedures (SOP)unmatched
Startupunmatched
Supply Chainunmatched
Support Documentationunmatched
Test Plan/Scheduleunmatched
United States Department of Energy (DOE)unmatched
Validation Testingunmatched
Writing Skillsunmatched
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