E Rugel Location: Paterson, NJ 07522 ... s quickly, team player, punctual, and loyal. Languages: Fluent Spanish/English and excellent translator Professional Experience: May 2008 – presentParagon MedicalFairfield , NJ Document Controller Specialist Ensure all Quality Management System documents are properly controlled, maintained and protected. Continuous analysis and improvement of document control protocols, systems, and processes, ensuring both internal and external regulatory requirements are met, including maintenance and improvement of facility wide training and training tracking system. Maintain an in-depth working knowledge of ISO and FDA requirements. Responsible for reconciliation and training of document ...
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E Dow Location: Princeton Junction, NJ 08550 ... leigh Healthcare is a manufacturer and distributor of medical devices. The product lines include DVT Prophylaxis Equipment, Patient Transport and Positioning equipment and Handheld Dopplers. I am responsible for all functions within the Quality and Regulatory areas that are regulated under 21 CFR - Part820 (Quality System), Part 803 (Medical Device Reporting), Part 806(Medical Device Corrections and Removals) and Part 821(Medical Device Tracking). I also serve as the Official Correspondent to the FDA. The manufacturing sites were certified to ISO 13485. There was a harmonized system and approach to quality with all Huntleigh Healthcare globally throughout the world.FDA ActivitiesHuntle ...
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C Michel Location: Elizabeth, NJ 07202 ... ll QA/QC's for validation.Super vise the different temperature readings of various food products. Supervise 18 employeesAdminis ter daily cleaning assignments of production facility while supervising production employees.Manage and maintain communication with USDA plant inspectors to follow through with current sanitary procedures. Manage organization of production through inspection and labeling of various machines and equipment used throughout plant.Inspects equipment and facility and communicates with maintenance staff and exterminators if neededMaintain communication with Production Manager and R & D Managers to ensure HACCP, GMP, and SSOP regulations are being met.Oversee c ...
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B Auch Location: Clayton, NJ 08312 ... ngton Township High School; High School Diploma Graduated 1996 Management Institute at Rowan University; Total Quality Management Course ISO 9001:2000 Training GMP (Good Manufacturing Practices) Training Time Management Manager/Supervis or Employee Training JCAHO Training American Society for Quality; Basics of Calibration Course Mechanical Technician Certification Internal Auditor Course (RABQSA Certified) US Food and Drug Administration; Is It A Device and How Do I Bring It To Market (13485/ QSR) (Bryan H Benesch Director of Compliance FDA Administrator) Experience Aerotek/ AALL American Fasteners Cinnaminson, NJ 2007-Present Quality Manager/Complian ce Consultant (Contractor) Ass ...
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A Lulla Location: Belle Mead, NJ 08502 ... and scope, executing Work Breakdown Structure (WBS) and project plans, and managing cost.Ability to track and manage issues, develop risk mitigation strategy, review and monitor defects and escalate items that require cross-team and management attention.Highly experienced in program and project management, process customization and implementation, development of best practices and quality assurance audits.Managed all phases of System and Process Development projects using Software Development Life Cycle (SDLC) methodology.Exce ptional interpersonal, communication, analytical and problem solving skills.Excellent presentation, facilitation, leadership and organizational skills, self directed ...
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E Horner Location: Westampton, NJ 08060 ... tems management, ISO compliance/certi fication, and productivity/qua lity improvements. Demonstrates highly analytical and strategic ability in supplier management, 8D corrective actions, Six Sigma Team Leadership, and internal auditing. Extremely focused on identifying system deficiencies, minimizing issues, and achieving successful solutions along with cost reductions. Combines expertise in project planning, implementation, team building, communication, and staff development. Team player with the ability to consistently provide high-level systematic standards of performance.EXPE RIENCEArtegraft, Inc, North Brunswick, NJ 2006-Present ...
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S Sripathi Location: Flemington, NJ 08822 ... tems Engineering / Quality Assurance / Release Management PROFILE · 6+ years of Quality Assurance experience with web, database, networking and OAMP applications. · 3 years of experience in software configuration and release management. · 2 years of exposure working in an offshore software delivery model. · Knowledge of SQA process in telecom, pharmaceutical and insurance projects · Expertise in manual and automated testing methodologies, tools and scripting. · Experience in Document Requirements Traceability, Test Strategy, Test Plans and Test Cases · Self-motivated team player with effective communication and collaboration skills. EXPERTISE Testing: Functional, Re ...
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D Patel Location: Lake Hiawayha , NJ 07034 ... my technical and managerial experience, as well as strong technical and organizational skills.QUALIFICA TIONS: Several years of experience in Quality Control & R eliability related tests that support new product qualifications. Process change qualifications, supplier qualifications, product evaluation, engineering level reliability test and product monitors.EXPERIE NCE: Biomet Inc., Parsippany, NJ 2008-Feb, 2010 QUALITY CONTROL INSPECTOR • Independently responsible for incoming, in-process, final assembly, and packaging ...
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M Robertson Location: Jackson, NJ 08527 ... etrology, IT Quality Systems * Computer, Software, IT, Equipment, Instrument, Sterilization, Cleaning, Clinical Trial, Utility, Quality Systems, MES, MRP, Laboratory Analytical Equipment, Instrumentation, SLDC, GAMP, Risk based approach Validation * Quality, Validation, Compliance, GMP/GLP/GAP/GCP/ GxP, Operations, Change Control, CAPA, Metrology, Automation/Proce ss Control, Management expert with 20 years experience in FDA regulated environments * Consistent track record for providing definitive quality assurance, validation, audit, compliance, and technical expertise for quality and laboratory software, IT, analytical systems, calibration management, 21CFR Part 11, MES, MRP, h ...
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K Golden Location: Wayne, NJ 07470 ... gy industry. Possess strong organizational skills and excellent analytical, problem solving, interpersonal, and oral and written communication skills. An enthusiastic team player or self-directed independent employee, able to quickly and thoroughly gain expertise in a particular field and integrate new information with existing knowledge. Technical expertise: Design Control compliance, Design Verification and Validation, Pre-Production Quality Assurance, Quality Control laboratory testing and data analysis, Quality Liaison for Regulatory Submissions and Quality Management representation on cross company, cross-functional teams in the development of in-vitro diagnostic products i ...
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