Margaret (Peggy) LeClair

EXPERIENCE OVERVIEW

Motivated Documentation Process and Control Manager with experience that includes Product Lifecycle Management (PLM) and Material Requirements Planning (MRP), Standard Operating Procedures (SOP) creation, and Corrective and Preventive Action

(CAPA) integration in an FDA / ISO regulated environment. Competencies have included leading and/or coordinating implementation of documentation and quality records management systems, project management, and purchasing for projects. SOFTWARE

Oracle Agile Product Lifecycle Management System Manage Arena Product Lifecycle Management System SmartSolve Quality Software SAP Including S4/Hana, MAX, Macola and Sage MAS200 ERP Crystal Reports Label View Microsoft Office SolidWorks Weber Marking Labeling Program Adobe Illustrator, Acrobat & Photoshop Win SPC Statistical Process Control EXPERIENCE

Abiomed Inc, Danvers MA 11/2017 – Present

Document Control Coordinator, Configuration Management, Quality Systems Global leading provider of Medical Devices home of the Impella pump family providing circulatory support

• BPL (Business Process Lead) S4/Hana Change Control and Master Data leading the organization, Document Control Associates in change control in the new SAP S4/Hana project

• Lead and maintain Risk Management program along with Incident Investigations and Health Human Evaluation documentation

• Manage all Quality Systems Training for Danvers MA, Aachen DE and Japan

• Participates in all MDSAP and FDA audits as back room lead and SME

• Provide data analysis of change control and quality alignment for monthly QMS meetings, Management Review, including reporting metrics in accordance with outlined data requested by process/Project Managers and leads

• Manage export control for all products shipping from Abiomed Sites including new processes in S4/Hana

• Administer all aspects of CCB and subsequent follow up of related tasks

• Research and resolve access/approval issues resulting in management of approving changes and Regulatory assessments within SAP & S4 environment

• Create, advise, manage, and support document control team on yearly goal creation, periodic follow up and input to Success Factors EMS system. Continually revisit as needed depending on corporate initiatives during the fiscal year. Amphenol PCD Beverly MA 12/2016 – 11/2017

Document Control Administrator, Configuration Management, Quality Assurance Interconnect products for military, aerospace, and industrial applications

• Part number, Bill of Material (BOM) and routing creation and maintenance in Macola ERP

• Statistical measurement input and maintenance of collection plans for incoming parts for connectors and cables using Win SPC

• Participate in team review and maintenance in user access/rules, manage change control and related teams

• Lead initiative for ERP system data user authorizations and integrity NxStage Medical, Inc. Lawrence MA 06/2016 – 11/2016 Change Analyst, Documentation Services, Quality Assurance (Contract) Hemodialysis machines, disposables and concentrates developed, manufactured, and distributed

• Monitoring, process and implement change orders in Agile PLM while maintaining quality compliance.

• Update applicable FDA standards and requirements to support R&D, Engineering and Supply Chain

• Update redlined procedures with applicable changes required to continue to support new product introduction and associated processes

• Create change orders to implement new processes required by Quality Management System (QMS)

• Create and maintain employee training records in electronic software database system. Medtronic Advanced Energy, Portsmouth NH 2012 – 2015 Configuration and Documentation Management PLM Administrator Electrosurgical medical devices used by doctors to perform orthopedic, spinal, surgical oncology, plastic and reconstructive surgery.

• Create, implement, support, and finalize engineering change requests and orders (ECR/ECO) Arena/Agile in PLM.

• Update and edit technical documents, clinicals and CAD drawings to engineering and supplier requirements.

• Assist additional Medtronic sites in the implementation, use, and administration in electronic document control strategies of new Agile PLM software. Initiate SAP access for new users.

• Continuously aid IT in new updates to Arena/Agile PLM and assist users with training and maintenance, including but not limited to implementation and managing user access.

• Coordinate desktop publishing and PLM translations for product labeling creation and changes.

• Create, manage and update required print on demand product labeling.

• Perform file maintenance of BOM's, parts drawings, ECR/ECO's, process alerts and other customer documents using PLM system and SAP. Lead the introduction and testing of additional modules and configuration of SAP BOMs for production and distribution.

• Participate in global Local Data Administrator (LDA) meetings in site management lead role for Surgical Technologies Division. Incorporating process and maintained data for all related global SAP system.

• Coordinate ECO status with customer and implement cost changes and effective dates; member of Product/Project teams, ensures projects are in compliance with the PLM Quality Management Systems, document and design control policies and procedures through Design Control Phase Reviews along with Regulatory Compliance folders for Technical Files.

• Create and Maintain Design History Files (DHF) and Device Master Record (DMR) file configurations in Arena/Agile PLM.

• Ensure PLM data accuracy and completeness of documentation including logs, reports and distribution including user access administration and access rights.

• Maintain and tracks PLM product configuration and manufacturing/customer requirements; facilitate the interface, including the use of the configuration review board, between program manager, engineering, manufacturing, and materials to ensure appropriate changes are documented.

• Analyze information and evaluate results to choose the best solution, solve problems and address PLM/ERP issues accordingly.

• Use relevant information cGMP and individual judgment to determine whether events or processes comply with quality, laws, regulations, or standards and assist with CAPAs.

• Maintain Quality System training documents, SOPs, risk analysis, failure modes Work Instructions, and Forms and aid in employee training within PLM/SAP.

• Support Corporate Medtronic as site lead LDA (Local Data Administrator) in SAP/PLM as regulatory and process requirements manager for product and project commercialization initiatives and new product introduction. Churchill Medical Systems, Vygon Corporation Dover NH 1995 – 2012 Custom Quoting Specialist / Purchasing and Planning / Quality Assurance Neonatology, pediatric and adult markets with a focus on vascular access and enteral, parenteral and IV delivery of nutrition and medications

• Manage customer quoting/customer service for all Vygon US exceptionally detail oriented.

• Managed all system access within company ran daily Material Requirement Planning for production

• Participated in quality customer complaint tracking, GMP, corrective action, non-conformance, and investigation.

• Lead and participate in Team initiative to redesign warehouse to better comply with necessary product movement from and to the sterilizer

• Acquired vendor information and attained quality and regulatory clearance for purchased products. Including but not limited to qualifying vendors and reviewing supplier documentation in relation to CAPA, performance and specifications required.

• Designed artwork, packaging and labeling for Vygon products as well as customer OEM products.

• Participated in multiple FDA and ISO audits including internal quality/CAPA audits.

• Maintained internal computer systems, workstations, and helped in designing the company’s website. Lead, manage implementation of new ERP system upgrade from MAX MRP to MAS 200 ERP.

• Directed yearly inventory, warehouse activities and managed supply chain requirements as needed.

• Sourced additional suppliers to be validated and added to companies approved supplier list (ASL). Performed supplier audits to verify availability, quality, and conformance to company standards.

• Purchased and planned inventory using MAX & MASS 200 MRP system requirements.

• Directed/Consulted Purchasing, Planning, Human Resources and Expediting departments with manufacturing requirements. Implemented teamwork environment to attain quality policy review and advised of potential improvements warranted. Managed, prequalified approved/proposed suppliers, and subcontractors, evaluation, and acceptability of products and/or services.

• Supported/Created and implemented of conversion of ECO's into Grand Avenue software.

• Created, maintained, and implemented ECO’s, new products Device Master Records (DMR), bill of materials (BOM), and routings resulting in validations of successful new products.

• Creating multi-level BOM from approved quote by customer into ERP systems.

• Specific outline of drawing (IV extension sets) labeling list of customer kit lineup reflected in the routing (Work order flow)

• Revision, creation of operating procedures reflecting the correct flow of work and assembly.

• Extensive tracking and follow up with internal and external customers to successfully implement approved changes outlined in the request for change.

• Suggestions in the change of current methods to increase productivity as direct results from time studies.

• Successfully trained and worked with 7 computer software programs independently with very little supervision or training.

• Managed outsourcing and purchasing of medical kits and sets resulting in substantial savings

• Cost savings regard to sourcing, purchasing acceptable parts for use in medical Implantable Catheters, kits and sets. EDUCATION

Graduate Spaulding High School Rochester NH

United States Navy, Naval Hospital/Nursing Corps School National American University, CMII-15 Configuration Management, and IPE The Institute for Process Excellence CMII Certification (Affiliate of Perdue University)

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