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A talented, detail oriented engineer with a diverse background in Product Development, Design Control, and Quality Engineering. Thrives on finding solutions to difficult challenges and executes quality results. Passionate natural leader who takes on ownership and drives projects to completion. Full breadth of knowledge on product development cycle, FDA medical device regulations and controls, CAPA investigations and completion, and global quality remediation. Experienced in project management, technical documentation, design and development, and document control Proven record of taking products through all stages of the product development cycle from product conceptualization through post-market releaseCollaborating with cross-functional teams to ensure timely completion of project (i.e. manufacturing, purchasing, logistics, QC, regulatory)
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Maxx Orthopedics Inc.Havertown, Pa, Us
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Quality EngineerMaxx Orthopedics Inc. Dec 2023 - PresentPhiladelphia, Pennsylvania, Us
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Contract Sustaining EngineerCook Medical Jun 2021 - Mar 2023Bloomington, Indiana, UsMaintain and remediate legacy design history files (DHFs), technical files, and risk management files of Class II devices as part of EU MDR certification Performed complaint analyses to determine hazards and hazardous situations to serve as a baseline for remediationCoordinated with cross-functional teams of regulatory affairs, quality assurance, manufacturing, engineering, and product management while maintaining project timelinesExpanded clinical knowledge in vascular embolization techniques and surgical procedures -
Contract Supplier Quality EngineerJohnson And Johnson Md&D Depuy Synthes Jan 2017 - Jan 2021• Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products. • Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. • Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO). • Report on contract manufacturer performance metrics. • Handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities. • Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
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Contract Validation Engineer -Technical File RemediationJohnson And Johnson Md&D Depuy Synthes Mar 2016 - Jan 2017Global company focused on trauma and CMF implants and instruments • Review and remediation of Verification and Validation and Risk Management documentation• Generated engineering rationales to encompass legacy parts into current international quality standards• Lead of the Production Risk Management team responsible for managing offshore members of the risk documentation team and ensuring final product quality and delivery under challenging timelines • Worked within a larger team on remediation of design control documentation to ensure compliance with international standards
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Engineering ConsultantZimmer Biomet Knee Creations Jun 2015 - Mar 2016Warsaw, Indiana, UsProven company focused on novel joint preservation technology for knee, ankle and hip osteoarthritis • Responsible for incorporating 2D data matrix barcodes on all Class II FDASIA sterile implant packaging labels per FDA Unique Device Identification (UDI) requirements• Led IQ, OQ, and PQ validation activities for installation of manufacturing barcode verifier equipment and labeling software• Responsible for GUDID attributes spreadsheet population and submission to FDA.• Assisted in the resolution of audit findings and CAPA investigation and completion• Assisted in the development and maintenance of QSR quality system• Maintained supplier quality records and audit documentation -
Product Development EngineerKnee Creations, Llc Nov 2010 - Jun 2012• Project leader responsible for development of unique femoral navigation guide system for company technology platform• Utilized good document control practices to create function and design specifications, SOLIDWORKS models, detail prints, and design history files (DHF)• Interacted with surgeons, sales, quality, regulatory, manufacturing, and operations to drive timely completion of project and launch to market to meet company objectives• Led efforts for successful commercialization, training, and market introduction of new surgical technique and instrumentation• Developed multiple devices from concept to first human use under challenging timelines• Assisted in the development and maintenance of QSR quality system• Identified and evaluated OEM suppliers for strategic partnerships
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Project EngineerGlobus Medical Aug 2007 - Nov 2010Audubon, Pa, Us• Project leader responsible for development of minimally invasive lateral intervertebral fusionsystem for company• Led efforts for successful commercialization, training, and market introduction of novel spinal interbody fusion products• Utilized good engineering practices to create function specifications, PRO-E models, detail prints,tolerance stacks, and design history files for multiple product lines• Collaborated on the design and development of balloon catheters for kyphoplasty system• Interacted with surgeons, sales, regulatory, manufacturing, purchasing, operations, and logistics to drive timely completion of project and launch to market to meet company objectives• Collaborated with Project Managers to develop, execute and update project plans. • Developed test methods to evaluate and develop new designs within ASTM standards. • Identified and evaluated OEM suppliers for strategic partnerships -
Associate Project EngineerGlobus Medical Apr 2006 - Aug 2007Audubon, Pa, Us• Project leader responsible for development of minimally invasive lateral intervertebral fusionsystem for company• Led efforts for successful commercialization, training, and market introduction of novel spinal interbody fusion products• Utilized good engineering practices to create function specifications, PRO-E models, detail prints,tolerance stacks, and design history files for multiple product lines• Collaborated on the design and development of balloon catheters for kyphoplasty system• Interacted with surgeons, sales, regulatory, manufacturing, purchasing, operations, and logistics to drive timely completion of project and launch to market to meet company objectives• Collaborated with Project Managers to develop, execute and update project plans. • Developed test methods to evaluate and develop new designs within ASTM standards. • Identified and evaluated OEM suppliers for strategic partnerships
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Product Development Engineering Co-OpSynthes Apr 2004 - Sep 2005Raynham, Ma, UsDesigned and developed implants and instrumentation for cranio-maxillofacial anatomy.Utilized PRO-E CAD software to model and detail designMaintained DHF file for multiple projectsAssisted senior engineers and product managers with key PD assignments
Jamie Carroll Skills
Jamie Carroll Education Details
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Drexel University College Of EngineeringBiomedical/Medical Engineering
Frequently Asked Questions about Jamie Carroll
What company does Jamie Carroll work for?
Jamie Carroll works for Maxx Orthopedics Inc.
What is Jamie Carroll's role at the current company?
Jamie Carroll's current role is Quality Engineer.
What is Jamie Carroll's email address?
Jamie Carroll's email address is jc****@****ons.com
What is Jamie Carroll's direct phone number?
Jamie Carroll's direct phone number is +160982*****
What schools did Jamie Carroll attend?
Jamie Carroll attended Drexel University College Of Engineering.
What are some of Jamie Carroll's interests?
Jamie Carroll has interest in Social Services, Children, Economic Empowerment, Education, Science And Technology, Human Rights, Health.
What skills is Jamie Carroll known for?
Jamie Carroll has skills like Cross Functional Team Leadership, Spine, Medical Devices, Product Development, Manufacturing, Pro Engineer, Surgery, Fda, Design Control, Iso 13485, Disposables, Biomedical Engineering.
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