ROBERT J. CONWAY (Cell) 617-***-****

** ***** **** (Home) 781-***-****

ARLINGTON, MA 02474 adbdno@r.postjobfree.com

Professional Profile

Experienced, focused, innovative and detail-oriented Quality Assurance and Manufacturing professional with significant accomplishments in building teams, leading/motivating, training and problem solving. Recognized for commitment to team approach, streamlining of processes and cross-functional cooperation. EXPERIENCE: University of Massachusetts, Boston, MA 02125 2004 - Present Circulation / Public Services Manager

Oversee operation activities for the Joseph P. Healey Library in the Circulation / Reserve / Reference / Media Service Desks.

Maintain library collections, ensuring upkeep, maintenance and integrity.

Collection of Fines from patrons and reporting pertinent data to library administration.

Oversee budget control for the Circulation department and developed Excel Spreadsheet to assist in the library administration and other library departments in maintaining budgetary controls.

Manage schedules for all students and staff during the operational hours of the library

Developed metric reporting systems to address and reallocate library assets to meet customer service commitments

Developed and implemented a successful training model now utilized by all library departments.

Maintain building security in cooperation with the Public Safety Department at the University.

Establish and implement customer service standards at all service desks

Report weekly payroll.

Perform internal inventory control audits.

EXPERIENCE: Formatech Inc., Andover, MA 01810

2004 - 2004 Quality Assurance Specialist

• Maintain and support device history records (DHR), including records archiving.

• Generated Engineering Change Requests (ECR) for instruction documentation.

• Managed reporting process for the Material Board (MRB) that detected and reduced discrepant material which enhanced engineering workflow.

• Successfully served as C.A.P.A. System Administrator; reported and documented Corrective and Preventive Actions; assisted in the resolution of Customer Complaints, instituted Corrective Action for Suppliers; revolved issues from Material Discrepancy Reports.

• Performed Internal and Supplier Audits per ISO 9001and per FDA requirements. EXPERIENCE: MedSource Technologies, Norwell, MA 020**-****-**** - 2004 Quality Assurance Systems Administrator/Supervisor

• Successfully streamlined inspection criteria to ensure compliance with GMP guidelines thus increasing efficiency and improving profitability.

• Maintain and support device history records (DHR), including records archiving.

• Generated Engineering Change Requests (ECR) for instruction documentation.

• Managed reporting process and Chaired the Material Board (MRB) that detected and reduced discrepant material which enhanced engineering workflow.

• Managed quality assurance group and enhanced performance by training, implementing cross training and supervising workers.

• Substituted for inspector for sub and final assemblies.

• Dramatically improved clean room operation by auditing and monitoring environment (class 10k to class 1k); wrote procedures to maintain clean room facilities.

• Re-organized the calibration system; coordinated equipment and ensured calibration cycles we met.

• Oversaw Returned Goods Authorization (RGA), expedited review and enabled engineering support to quickly resolve problems.

• Successfully served as C.A.P.A. System Administrator; reported and documented Corrective Action; resolved Customer Complaints, instituted Corrective Action for Suppliers; revolved issues from Material Discrepancy Reports and Internal Audits.

• Audited and internally reported on documentation and process control for ISO 9001 and per FDA and TUV requirements. Supported staff working with on-site agencies during verification and/or investigation audits. Robert J. Conway Page 2

EXPERIENCE: Thoratec/Thermo Cardio Systems/Thermedics, Inc., Woburn, MA 01801 1993 - 2003 Quality Assurance Supervisor (Thoratec/T.C.I.)

• Successfully reviewed and maintained department inspection criteria and recommend improved inspection criteria.

• Inspected the Heart Mate Heart Pump (LVAD), and all sub and final assemblies for the Heart Mate system and for R&D/ Development products.

• Resolved issues relating to returned goods and performed failure analysis which ultimately increased customer satisfaction.

• Accurately maintained device history records and computer yielding data for engineering analysis which improved engineering workflow.

• Reviewed and audited Engineering Change requests to ensure instruction documentation and drawings were completed and available.

• Reduced volume of discrepant products using innovative measures while increasing efficiency and productivity.

• Provided internal audits for documentation and process control for ISO 9001 and per FDA and TUV requirements. Served on the support staff for these agencies when onsite for verification or investigation audits.

• Trained and supervised quality assurance technicians.

• Evaluated and monitored clean room environment (class 10k to class 1k).

• Reviewed sterilization data and approved packaging and shipping of product.

• Maintained calibration records and coordinated equipment for calibration cycles. 1994 - 1996 Quality Assurance Group Leader (Thermedics)

• Inspected components, raw materials and medical grade multi-lumen tubing.

• Review of acceptance criteria of intercompany and vendor accounts.

• Audited of production line yields using S.P.C. guidelines.

• Established and maintained collaboration of QA and manufacturing equipment 1993 - 1994 Clean Room Manufacturing Technician (T.C.I.)

• Oversaw sterilization, heart pump components for assembly and implantation.

• Assembled Left Ventricular Assist Device (LVAD)

• Prepared Chemical/Acid for cleaning of individual components relating to the ventricular assist device and Autoclaved assemblies.

• Maintained clean room environment (class 10k to class 1k) including per written procedures.

• Packaged sterile/non-sterile assemblies and final pumps.

• Reviewed up-date of written procedures for engineering review. Prior Experience: Loral Infrared & Imaging Systems, Lexington, MA 02473 Manufacturing Engineering Technician

1980 - 1991 • Sustaining engineer for Manufacturing Engineering Group dealing with components, sub assembly and final assemblies for major government defense contracts.

• Operators certification for soldering per Mil-S-45743 and Mil-S-2000.

• Assist manufacturing by training personnel on critical operations.

• Perform analysis on both first pass and returned goods for the manufacturing/ project and quality engineering.

• Provide documentation and process control audits per MCAS requirements

• Familiar with Macintosh PC, Lotus, Honeywell DPS 8 system.

• Administrative interface between manufacturing and configuration management.

• Documentation Coordinator responsible for manufacturing and engineering.

• Review and initiate engineering changes to assembly instructions and related drawing documentation for manufacturing.

Quality Assurance Inspector/Engineering Technician

• Sustaining engineer for Quality Assurance Engineering Group dealing with components, sub assembly and final assemblies for major government defense contracts.

• Lead technician for several facets of infrared detector component manufacturing.

• Founding member of a successful pilot Quality Circle group for the Electro-Optics Division. EDUCATION: 1991- 1992 Minuteman Regional Vocational Technical School, Lexington, MA Biotechnology Manufacturing Technician Program

Studies included: Media Prep, Cell Culture, Reading/Writing SOP's, Basic Electronics, Basic Biology, Basic Chemistry, Process Control, Computer Science and Communications. Arlington High School, Arlington, MA, Diploma

Northeastern University, Burlington, MA attending Courses in Business Management

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