V. Carol Graves

Experience

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  C. R. Bard

  Sept 1990 - Mar 1994

  Inspector/ Machine Operator

  Assembled and packaged coronary catheters at different stages throughout the processPerformed quality inspections at various stages of assemblyUtilized inspection tools such as micrometers, calipers, tensile testers, ring gauges, and laser micrometersOperated Royal Master Auto Grind Tippers and Grinders, and Newbury 30 Ton Injection molder

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  Acro-Matic Plastics, Inc.

  Oct 1995 - Sept 1997

  QC Inspector

  Started working for company as a machine operator, was promoted into the role of QC InspectorPerformed in-process inspection of high precision automotive and medical productsInteracted with manufacturing to resolve quality issuesResponsible for well-maintained quality recordsOperated a variety of injection molding machines, mostly NisseiPerformed break operator functionsWorked with Secondary Operations for the inspecting, packaging, and labeling of parts Show less

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  C-Plastics Corp.

  Oct 1997 - Feb 2000

  Document Control Specialist

  Started working for company as a QC Inspector, was promoted into the role of Quality Administrative Assistant (Document Control Specialist)Helped company accomplish goal of ISO 9000 certificationParticipated in Management Review meetings and generated reports and meeting minutesResponsible for data entry and generation of Corporate ReportsPerformed Document Control functions using various Lotus programs, and created several linked databasesConducted internal quality audits per ISO/ QS standardsProvided employee training on various aspects of the Quality SystemsCalibrated equipment through use of Gauge R & RInteracted with vendors about various quality issuesPerformed incoming, WIP, final inspection; and WIP inspection of product at contractor location as needed Show less

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  Anderson Power Products

  Feb 2000 - May 2002

  Senior QC Inspector

  Directed 2nd shift inspection/ weekend inspection activitiesPerformed incoming, in process, and final inspections on high voltage connectors and assembliesProgrammed and operated the OGP vision systemCreated and implemented an electronic dimensional data storage databaseConducted internal quality audits per ISO standardsAssisted in training new hires on quality issuesActively participated and contributed to the Order Fulfillment Team

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  BioValve Technologies, Inc.

  Jun 2002 - Sept 2004

  Document Control Specialist

  Started working for company as a QC Inspector, was promoted into the role of Document Control SpecialistResponsible for internal document control system, including document and part number assignment, processing of all ECOs, making modifications to SOPs and DOPs in accordance with cGMP requirements, maintaining systems documents, ensuring document currency and availability, and archival of prior revision documentsReviewed all documentation for accuracy, cross-references, and completenessDeveloped and maintained the systems databases including the Document Master List, Part Number and Document Number Issuance Database, Approved Supplier Database, Non-Conforming Material Database (MRB), Receiving, Inventory Control, and Engineering Change Order LogsSet up the Quality Department Receiving, Inspection, and Document Control filing systemImplemented flowcharts for various internal processesInteracted with vendors to resolve receiving issuesCoordinated and prioritized daily inspection priorities for two incoming inspectors Show less

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  Scandius BioMedical, Inc.

  Sept 2004 - Jul 2008

  Sr. Document Control Specialist

  Started as QC Inspector, promoted two times (Doc Control, Sr. Doc Control)Helped company accomplish goal of ISO 13485 certificationMaintain & enhance company controlled records process while providing oversight and assistance to other functions in record retention (at policy, procedural, and instructional levels)Ensure currency, relevancy, & availability of utilized external standards & purchase updated and new standards as necessaryProvide training & support on documentation and quality systems including but not limited to record retention, CAPA, Internal Auditing, and the ECO (Engineering Change Order) processOversee Internal Auditing & CAPA systems in addition to Document Control responsibilities and interact with departments to ensure continued forward progressSupport Engineering projects & product line upgrades, including attending and participating in project meetings, and expediting critical Engineering Change OrdersProvide support to all departments during post-acquisition activities to transfer Operations/ Quality functions from the Littleton facility to other facilities, including the obsolescence of systems and implementation and user training of new systems and softwareWrite, review, & revise documentation in accordance with established QualityAssign & track part numbers, catalog numbers, document numbers, ECO numbers, document distribution, and formulate new systems as business needs change, while maintaining a high degree of accuracyEncourage effective communication throughout all levels of the organizationCoordinate & administer internal document control system, including continuous improvement initiativesInitiate system re-writes for ECO, CAPA, Non-Conforming Material, and Document Control systems; assist in system re-write for Internal Auditing; provide employees with retrainingImprove upon documenting training requirements for each employee, and the notification processSupport implementation and integration of ERP system Show less

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  Straumann

  Aug 2008 - Nov 2008

  Quality Systems Specialist

  Oversee Internal Auditing and CAPA systems, interact with departments to ensure continued forward progressWrite, review, and revise documentation in accordance with established Quality SystemsCompile metrics and assemble into reports for distribution and inclusion in management review meetingsParticipate in CE annual audits

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  RainDance Technologies

  Mar 2009 - Sept 2013

  Document Control Specialist

  Coordinate and administer all aspects of the document control system in a Quality Department comprised of two persons for a 85+ person company, including processing all Change Requests, maintaining Quality Systems documents (NCMR, CAPA, Audits, Rework, Calibration, Training, Deviations, DMRs, Batch Records), ensuring document currency/revision accuracy and availability while developing and utilizing Microsoft SharePoint Intra-net system, archival of prior revision documents, training and release notifications, Batch Record issuance, review, and release, scanning and posting, filing and organizingCreated the Quality Department Receiving, Inspection, and Document Control filing systemParticipate in TUV Factory Safety Audits on a quarterly basis Show less

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  ResTech Plastic Molding

  Sept 2013 - Feb 2014

  Document Control and Work Instruction Specialist

  Generate all Operator Work Instructions into a detailed yet simple and user-friendly format using images, descriptions, and videosIssue internal monthly metrics, and customer communications regarding inspection data and charts/graphsParticipate in frequent audits, both vendor and customer, as well as ISO (external and internal)Provide quality customer support throughout entire company, every departmentWork with Operators and Group Leads to provide comprehensive training on systems and instructionsCoordinate the purchasing of supplies for the Quality Department, ensuring seamless daily operationEfficiently process Engineering Change documents to keep all departments running fluidly – this entails all ISO systems documents, as well as hundreds of customer supplied drawings and specs, and internal Quality Inspection Procedures (Incoming, In-process, Secondary Operations, and Final) Show less

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  Viatar LLC

  Mar 2014 - Mar 2017

  Quality Systems Specialist

  Manage all aspects of the Quality Department (CAPA, NCMR, Audits, Calibration, Inspection, Batch Records Creation/Review, Training, Change Control, External Standards, Laboratory Notebooks, records retrieval, issuance, and archival)Support for Management Review – compile Quality Metrics, create and edit slides, schedule meetings, generate meeting minutes, issue periodic reminders to keep Action Items on trackParticipate in annual internal audits performed by an external company, and surveillance and recertification audits by the notified body BSI, and act as the informal lead and contact for those audits; significantly improved upon the number of audit findings for bothSuccessful completion of a 4-day ISO 13485:2016 Lead Auditor class held by BSIAssist with a critical supplier auditExpand and improve the company document sharing repositories on SharePoint and the secure network drive, as well as implement a training portal utilized by all employeesGuide and mentor interns and junior engineers (Quality Systems and ISO)Serve as the first point of contact within the company (greet and handle visitors and solicitors), perform office duties such as ordering supplies, run errands as required, pay company bills with the corporate credit card, remain in constant contact with the CEO and sending him mail and email correspondences as appropriateAssist with cell cultivation in a BSL-2 lab as a backup as requiredPerform shipping and receiving activities for the companyManage the company’s OSHA/Safety/HazCom program, create the first chemical inventory log, obtain SDS sheets as appropriateCreate the first company Asset List; file with the City of Lowell for Personal Property Taxes on behalf of the CEO Show less

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  MicroMedicine Inc.

  May 2017 - Aug 2018

  Quality Systems Specialist

  Assisted Quality Manager in creation of QMS for early startup companyMaintained the Change Control system and implemented processes to improve upon the flow and turnaround time (paper-based system)Reorganized document storage on the BOX file sharing platform to assist with easier navigationCreated first comprehensive list of calibrated equipment and coordinated calibration efforts to maintain complianceServed as a planner and coordinator when the business moved from the Watertown location to the Waltham location, ensuring minimal downtime and impact, and coordinated calibration activities for the instruments impact by the move Show less

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  Convergent Dental

  Aug 2018 - Oct 2021

  Sr. Quality Systems Specialist

  Maintain the Change Control process in the Omnify (Arena) PLM system and train system usersManage the calibration of more than 300 pieces of equipment, including ‘kits’ of 7+ pieces of equipment mailed to and from 16 Field Service Engineers across North America, equipment shipped overseas for calibration, and equipment calibrated both onsite and in the calibration house’s calibration labInitiated the change of the calibration vendor used that had long turnaround times and was unresponsive, to another widely known and well-respected vendor, resulting in drastically reduced calibration turnaround timesModify the Omnify PLM system as an administrator as needed to improve visibility of helpful information such as RoHS status for parts, ensure required fields are completed and submissions cannot proceed without them, and various process flow improvementsDeveloped new hire Onboarding information to help ease the transition into the company, and provide helpful pointers for navigating the PLM systemAssisted with the launch of the ERP system NetSuite, which required system evaluations, resulting in modifications for the information stored and captured within Omnify to ensure the systems communicated with each other, as well as implementing updates to several impacted procedures and work instructionsInnovated during the challenging COVID-19 shutdown to ensure that the business could continue forward with as little impact as possible despite staff reductions, and supported the Quality Director during two remote Notified Body Audits during 2020Oversee training company-wide and take steps as required to ensure timely completion Show less

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  MicroPort NaviBot

  Oct 2021 - Apr 2024

  Sr. Quality Systems Specialist

  Responsible for daily support of Quality Management System (QMS), ensuring compliance with 21 CFR 820, ISO 13485Develop and/or improve related processes and documentationProvide training in related QMS areas of expertiseMaintain the company SharePoint site, ensuring timely and accurate data entry and file uploads, appropriately apply access permissions, add and remove users as required, maintain structure that is easy to navigate, while also maintaining a paper-based QMSManage key quality system aspects of the QMS including Change Control, Training, audits (internal/external/supplier), CAPA, Customer Complaints and NCMRSupports organization and facilitation (front and back room) of FDA, Notified Body (MDSAP audits), TUV SUD Inmetro auditsCollect and analyze quality data for continuous improvement opportunitiesReview Batch Records/DHRs for completeness and correctness Show less

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  Curadel Pharma

  Jun 2024 - Jan 2025

  QA Specialist

  Supporting Quality Operations and Quality Management Systems for internal and external operations, maintaining documents in compliance with business needs and regulatory expectations in addition to supporting process improvements in the document control and records management areas.Assist with formatting and administration of electronic document workflows as well as chain of custody, issuance, and archival of related QMS records, including training, CAPA, complaints, vendor qualification and audit activity.Support cross functional teams in processing document change requests, document approvals and archival.Support Regulatory Affairs with Quality reviews of source documents for submission modules of CMC sections as directed, participate in cross functional meetings with RA/QA activities when directed.Support Clinical Operations with document collection and quality reviews as directed to ensure the principles of good documentation practices are being applied. Show less

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  BrioHealth Solutions

  Apr 2025 - now

  Document Control Specialist