Document Control Entry Representative

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GRACE MARMORSTEIN, BA (Com.Arts)

*** ***** ****** ****, *******, NJ, 07652 Cell: 201-***-**** adqgpa@r.postjobfree.com PROFESSIONAL SUMMARY

A seasoned and highly experienced Senior Team Leader with more than 20 years of Medical device experience (Cardiac surgery and Cardiac assist and Vascular Intervention products in document control, complaints, orders, customer support, processing documents for quality, engineering, operations, regulatory, clinical and other key departments in the organization at three sites in New Jersey

(Mahwah, Fairfield and Wayne).

Currently seeking a challenging role in a progressive organization.

! A seasoned and experienced subject matter expert in Document management using the Windchill PLM systems, TrackWise QM, AGILE and SAP

! Senior Manager providing document support to all departments during FDA, TUV, BSI, Paraxel and other Regulatory body audits. Provides back room support while working with the Quality Compliance Manager and Senior Quality Director to set up meetings with regulatory bodies

! Contributes to root cause investigation and containment with the Corrective and Preventative Action (CAPA) team TECHNICAL SKILLS

! Microsoft Suite: Word, Excel, Outlook, Access

! Windchill PLM system

! AGILE

! SAP, VISIO

! TrackWise QM

! One Note, MS project

EXPERIENCE

Senior Manager, Reg. Document/Manager (Doc Services) May 2014 to Present Getinge https://www.getinge.com Wayne, NJ

Major Accomplishments:

Senior Quality Manager for Project synergy; Phase I that involved upgrade of the Windchill document management system for the CARDIAC SURGERY and VASCULAR business and Project Synergy Phase II that involves the transfer of documents, templates, and work instructions from another document management system i.e. TrackWise that involved more than 10,000 documents, parts and Bills of Materials in 9 months for the CARDIAC ASSIST business. Trained various departments in the organization with regards to consumer, contributor, reviewer and approver access in the latest WINDCHILL PLM systems. Responsibilities:

! Manages a team of 20 employees including both direct reports as well as dotted line employees at three different sites responsible for Cardiac Assist, Cardiac Surgery and Vascular product lines.

! Responsible for the Maquet Learning Management System (LMS). Presents strategies for compliance to training and audit readiness for all Getinge employees at three different sites in NJ

! Manages the department budget including budget forecasting, resource management

! Hiring manager for the Document control (Windchill PLM systems) department

! Trains and mentors new employees, manages employee performance and expectations and works on development plans

! Responsible for Global Initiatives while working with the Headquarters in Sweden and implements the same in local management systems

! Business process lead for Windchill PLM, TrackWise systems and is heavily experienced in the AGILE document management systems

! Responsible for upgrades, leading trouble shooting and training in document management system for all departments at three different sites at NJ

! Assures compliance with internal business process requirements in addition to external regulations.

! Lead document expert during third party audits and inspections from the FDA and other notified bodies such as BSI, TUV etc.

! Authors Standard operating procedures, manuals and work instructions for other department on the use of TrackWise and Windchill.

! Negotiates the External Standards service agreements with third party External Standards supplier (e.g. IHS)

! Develops Doc Services personnel and creates succession plans within Doc Services.

! Manages the distribution of controlled documentation and oversees the successful archiving of controlled documentation and records.

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! Responsible for continuous improvement of business processes.

! Disseminates documentation that includes “corporate” global documentation while auditing the same to see that it controlled and shared among Maquet sites

! Maintenance of Quality records archives of hard copy data for validations, weaving patterns, oven software, legacy change requests, current site documentation (up to date Shop Floor Paperwork - as a contingency), laboratory notebook issuance and maintenance; design history files.

! Work with Manufacturing managers, supervisors and leads to facilitate Shop Floor Paperwork changes and corrections as needed and to implement Production Order changes

! Facilitates the annual roll up of labor and overhead hours for routings with the Finance and IE depts. Complaints Analyst I January 2013 to May 2014

Getinge https://www.getinge.com Wayne, NJ

Major Accomplishment: Remediated critical care complaints documentation and processes. Streamlined and revised Standard operating procedures as a part of continuous improvement processes Responsibilities:

! Provided team metrics while working with members of the MMS Quality assurance Complaints group

! Processed complaints for Importer responsibilities in a timely, accurate and complete manner

! Provided subject matter and technical expertise to other departments within functional area

! Worked with other departments such as medical and clinical to provide information for Health Hazard Evaluation (HHE) processing

! Reviewed and maintained department Standard operating procedures to provide improvements to work processes

! Reported on trending of complaint metrics for different product lines that involved Cardiac surgery products.

! Presented critical information of Complaint Reviews at department meetings to be presented to management review

! Ensured timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries.

! Responsible for communicating business related issues to senior management.

! Provided Quality control

! Processed product complaints while maintaining compliance to all regulations.

! Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives

(MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance

(MDV) and reportability requirements for various countries.

! Assisted with Product Field Actions.

! Collected follow up information related to complaints from customers, typically through the Sales and/or Field Service groups.

Document control coordinator Sept 2001 to Dec 2012 Getinge https://www.getinge.com Datascope Corp, Mahwah, NJ Major Accomplishments: Individual contributor/ manager and processor for document control supporting various departments in the organization

Responsibilities:

" Organized, maintained and created documentation through the Quality Management System.

" The sole document coordinator responsible for verification, checking in, collate and circulation for all engineering, operations, quality and regulatory documents.

" Implementation and final processing and release of all documents

" Responsible for product hold routing, notifications and timelines

" Rejected change notices that had incomplete or inaccurate documentation from other departments and worked to resolve issues.

" Ensured that other departments in the organization adhered to applicable standard operating procedures to maintain compliance with regulatory bodies

" Administered and oversaw the release of Engineering Part Number requests

" Chairperson for the Change Control Board meeting, while ensuring timely and correct implementation of all Change Requests that are pending approval.

" Maintained and approved the Approved Vendor List

" Administered lab notebooks

" Supporting testing and validation of the TrackWise quality management system

" Responsible for archiving and maintenance of the design history files

" Managed and maintained work instructions used on the production floor for the Cardiac assist business

" Responsible for all trainings and standard operating procedures for document control management system Page 3 of 3

Order control coordinator Dec 1996 to Aug 2001

Getinge https://www.getinge.com Datascope Corp, Paramus, NJ Major Accomplishment: Development of a standard operating processes and required work instructions to coordinate processes with various departments i.e. planning, purchasing, and packaging Responsibilities:

" Processed and allocated equipment for shipments of medical devices (Cardiac assist and Cardiac surgery)

" Generated shortage reports when devices were in shortage and coordinated replenishing shortage with purchasing and planning departments

" Held daily/ weekly and biweekly meetings with planning to generate shipment schedules

" Worked with the packaging department, shipping departments

" Reported equipment shortages and worked with Planning and Purchasing to expedite delivery Supervisor, International Customer Service Apr 1987 to Dec 1996 Getinge https://www.getinge.com Datascope Corp, Paramus, NJ Major Accomplishments: Testing/Validating and Implementing the ASK MANMAN/ OMAR SOFTWARE system Responsibilities:

" Oversaw order processing operation and ensured orders are processed for worldwide customer base via distributor network and subsidiary offices while using standard operating procedures.

" Verified customer credit line increase status and reported the same to Corporate International Credit officers.

" Validated Letters of Credit enabling orders to be released for rapid turnaround.

" Worked with Materials Manager to guarantee product availability in order to expedite shipments.

" Created and maintained worldwide dealer directories containing pertinent information relating to customer requirements.

" Sole customer service contact and coordinator for Division customer / distributor network and key accounts, include: contact with service / technical departments to troubleshoot / analyze problems, expedite critical parts shipments, arranging for exchange and or loaner equipment.

" Controlled detailed pricing and discount tables for each individual distributor territories.

" Processed requests for quotations on spare parts and accessories including information on price, availability, weight / dimensions, freight costs and terms.

" Provided International Sales / Service groups with pricing and availability of various products to ensure up-to-date information.

" Reported on daily bookings concerning sales dollars and units to executive management.

" Member of a computer implementation team created and assisted with the startup of a new mainframe HP-3000 system running ASK MANMAN / OMAR software to replace the present IBM system 38. Order entry representative Aug 1985 to Apr 1987

Getinge https://www.getinge.com Datascope Corp, Paramus, NJ Major Accomplishment: Development of a standard operating processes and required work instructions/logs for the order entry process. Responsibilities:

" Processed customer / dealer orders received via telephone and or mail, including verification of price, checking availability, and calculation on buying group or contract discounts.

" Worked with service organization on the service inventory and shipments

" Worked with customer service department with replacement orders for customer complaints

" Metrics on time customer shipments

" Maintained the "Do Not Ship" order log and updated it monthly with status of customer account either by contact with sales representative or customer directly.

" Responsible for data entry of International orders and reporting. EDUCATION

B.A. Communication Arts

Marist College, Poughkeepsie, New York

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