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 ...
97 hits
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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 ...
95 hits
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J Moore Location: Lyndhurst, NJ 07071 ... eer Profile Accomplished Quality Control Manager offering a solid educational background, extensive experience and a strong record of Quality Control Laboratory supervision. Significant qualifications include: An extraordinary blend of leadership, and organization Recognized for keen abilities to operate a functional and efficient 24/7 Quality Control Laboratory Impeccable ability to communicate with all levels of plant operations, as well as, with raw material vendors and customers Creative problem solving and trouble shooting skills Staying current on advancements in the field and networking with colleagues Continually achieving high levels of prod ...
93 hits
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V Adama Location: Edison, NJ 08817 ... logies and Test Reports, automated testing of various Client/Server and Web applications in Finance, Insurance, Aviation and Telecom domains using enterprise automated testing tools like QTP, WinRunner, TestDirector and LoadRunner. Also possess strong understanding and experience in using Microsoft .Net and Java applications. Expertise: · Extensive experience in Automated Testing and Strong knowledge of Software Testing Life Cycle · Strong Experience in developing and executing comprehensive Test Plans, Test Strategies and Test Cases · Strong experience MS Word, MS Excel for writing Test Plans, Test Cases, weekly status reports · Performed all phases of Testing Methodologies that ...
91 hits
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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 ...
89 hits
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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 ...
87 hits
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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 ...
85 hits
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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 ...
83 hits
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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 ...
81 hits
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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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