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Meticulous Quality Professional who excels at juggling multiple tasks and working under pressure. Broad industry experience includes Biomedical, Aerospace, Medal shop and Prototype Development. More than 10 year experience in the Quality system. Demonstrated leadership skills in GMP/QSR compliant Quality Management System implementation and continued compliance including managing CAPA and Post Market processes.
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Quality Assurance ManagerVisiblyHillsboro, Oh, Us
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Senior Supplier Quality Engineer Eu Mdr De Puy SynthesIntepros Consulting Apr 2018 - PresentWaltham, Ma, Plymouth Meeting, Pa, , UsFully RemoteEU MDR supplier outreach, MPI and PVE creationTraining related to EU-MDR gap assessment, planning and remediation.Reviewed supporting documents to meet EU-MDR requirementsInitiated new or revised documentation and tracks through appropriate approval cycles and implementation.Maintained a professional working relationship with internal and external customer and support staff and suppliers.Biocompatibility outreach which included Restricted substances, Materials of Animal Origin and Nano-materialsMaintained project plans and tracked project execution to timelinesWorked hand in hand with top tierand sub tier suppliersPrepared and presented oral and written project updates and technical discussions. -
Senior Quality Engineeer (Contracted For J & J, Spectranectics And Cardinal/Medtronic’S Projects)Alku Jan 2016 - Apr 2018Andover, Ma, UsSpectranectics:Warning letter remediation of multiple catheterprojects including laser ablation and supportcatheters. First team to complete project *early* andwas reassigned to other teams to help share lessons learned. Manager was nominated for most effective leader in annual company awards banquetValidation experience in Process Validations of Surgical and Non-Invasive manufacturing (reprocessing) lines, Physical Test Method Validation (Attribute agreement study/GR&R) and Equipment Qualification/Remediation. Process Validation - Verification of manufacturing equipment and inspection methods including revalidation of entire processes and implementing validations for newly introduced manufacturing lines, while minimizing deviations through careful protocol execution (Delivering validation items one month ahead of schedule).Review of all equipment qualifications (IQ/OQ-E/OQ-P) by product line during Spectronectics Remediation project including assessment of all qualification gaps and remediation of Process/PTM/Equipment gaps per corporate validation program.Notable accomplishments: DI/DO quality team leader for Quick- Cross product line. Component Qualification (CQ) quality team leader. The only contractor with signature authority for the remediation project. Completing five distinct TMV’s in two weeks.Cardinal/Medtronic:Investigating Customer complaints and executing PFMEA to assess Process/Equipment risk in determining the extent of validation. -
Senior Quality EngineerTerumo Cardiovascular Group Aug 2015 - Jan 2016Ann Arbor, Michigan, UsRemediation, process validation quality engineer.Worked with team of 20+ validation engineers toapprove validation protocols, data sheets, statisticalreports, and validation plans. Remediated riskmanagement documentation as well as process SOPsand QMS SOPs. After three warning letters, weremoved restrictions from consent decree withoutany observations, findings, 483s, or warning lettersduring post remediation Agency audit. This was dueto extensively pre-reviewing the work through ex-fdaauditors (consultants) and learning 1 on 1 theAgency's preferred documentation formats. Thisallowed the company to avoid severe fines, penalties, and lifted sales restrictions for first time in 4 years Authoring, and completing Test Method Validations (TMV’s) Risk assessment, troubleshooting, & root cause analysis on electronic systems, PCBs, & components Maintained Quality System in accordance with ISO13485, ISO9001, ISO17025, FDA QSR (21CFR:820)Project Technical Lead for QA-1 Project SurgeLead development efforts on FDA 21 CFR 820 Design History File (DHF) RemediationNCR remediation team leader -
Senior Quality Engineer IZimmer Apr 2014 - Aug 2015Warsaw, Indiana, Us• Supported on many CAPA projects and closers• PFMEA, DFMEA, and FMEA corrections and changes• CAPA owner and team lead• Managed complaints, brought open complaints to current status, closed a number of complaints opened for an extended period of time. Presented monthly updates to Executive board, with extraordinary progress in a short period of time.• Worked closely and interacted effectively with Regulatory and inspection to achieve successful results• Reviewed product and packaging labels, marketing literature, training materials, and IFU to ensure worldwide compliance -
Quality And Process EngineerApex Supply Chain Technologies Jan 2012 - Apr 2014Mason, Ohio, Us• Developed process and test reports for new prototype products throughout developmental phase.• Developed instructions and test procedures still used at company today.• Development of projects from design phase throughout production implementation• Developed methods and procedures for processes, measurement, documenting and work flow techniques.• Developed quality processes for products and established standard for continuous quality • Provide awareness and understanding of overall project portfolio, interactions and issues. -
Quality Process EngineerParkway Products Apr 2010 - Dec 2011Genas, Rhône, Fr• Develop process for new products for Injection/compression molding (Plastics).• Writing work instructions and procedures.• Planned, scheduled and coordinated detailed phases of large-scale projects.• Injection molding and CNC in process leader.• Identified the most efficient and acceptable resolutions to complex engineering problems. -
Quality ManagerVictory Industrial Products Mar 2004 - Feb 2010• Trained and developed employees on Quality Management Systems standards and internal auditing and corrective action programs• Managed quality systems including layouts, equipment procurement, installation, operations and certifications• Maintained open and effective communications with project teams to increase productivity.• Wrote protocols, qualification documents, and test reports to provide effective quality assurance. • Conferred with engineers and other personnel to implement operating procedures, resolve system malfunctions, and provide technical information.
Steve Crabtree Skills
Steve Crabtree Education Details
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Kaplan UniversityPsychology -
Aetc Us NavyComputer Science
Frequently Asked Questions about Steve Crabtree
What company does Steve Crabtree work for?
Steve Crabtree works for Visibly
What is Steve Crabtree's role at the current company?
Steve Crabtree's current role is Quality Assurance Manager.
What is Steve Crabtree's email address?
Steve Crabtree's email address is sc****@****lku.com
What is Steve Crabtree's direct phone number?
Steve Crabtree's direct phone number is +157426*****
What schools did Steve Crabtree attend?
Steve Crabtree attended Kaplan University, Aetc Us Navy.
What skills is Steve Crabtree known for?
Steve Crabtree has skills like Process Improvement, Lean Manufacturing, Manufacturing, Product Development, Project Management, Data Analysis, Operations Management, 21 Cfr, Part 820, Capas, Validation Reports, Process Qualification.
Who are Steve Crabtree's colleagues?
Steve Crabtree's colleagues are Lisa Mccullough, Mike Rahimzadeh, Brian Ambers, Cpa, Kevin Hundert, Henry Hamilton Clement, Victor Arhin, Henry Hamilton-Clement.
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