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JOYCE M. HARE

Objective

To obtain a career within the quality industry, that will facilitate my extended knowledge and experience as required. With keen attention to details and follow through skills, I have a proven track record of timely and effectively meeting daily and production schedules and projects.

Experience

2015-2016

TransMedic

Andover, Ma

Senior Quality Inspector

Exposure and conform to FDA, GMP, ISO 13485, 21 CFR 820 in a Medically regulated environment.

Incoming inspection of highly complex components and subassemblies.

Conducts final inspections for release of finished medical devices.

Thoroughly and accurately completes and maintains inspection documentation in a neat and orderly fashion.

First Article Inspection (FAI)

Coordinates MRB reviews of non-conforming components and assemblies.

Supports and participate in 3rd party audits.

Coordinates and performs preventive maintenance and calibration of all incoming equipment throughout the departments.

Contributes towards continuous improvement with regards to Quality and efficiency.

Perform other TransMedic tasks and duties as required.

2014-2015

St. Jude Medical

Westford, Ma

Senior Quality Inspector

Exposure and conform to FDA, GMP, ISO 13485, 21 CFR 820 in a Medically regulated environment

Performs visual, dimensional and functional inspection and testing according to documented policies and procedures. (Includes catheter and mechanical inspection)

Experience with inspection sampling techniques and plans

Proficiency with reading and understanding engineer drawings and blue prints

Records inspection and test data as prescribed by written instructions and procedures. Operates all associated test and measurement equipment as instructed and as documented in procedures.

Perform First Article, Initial and Final inspection

Inspection on electronic, mechanical parts and PCB assemblies

Knowledge in handling and inspecting Fiber Optics

Document all non-conformances in Non-Conforming Material Review system.

Good communication and computer skills, including Microsoft Word, Microsoft Excel, database entry, and use of statistical software packages.

Proficiency in SAP with respect to incoming material QC requirements

Daily and weekly meeting to ensure proper assessments and demands are met accordingly within facility

Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Support R&D with testing, data collection and analysis.

Assist R&D in the development, implementation and continuous improvement of process to produce products that meets customer’s requirement.

Interface with suppliers as required in support of material quality / technical inspection.

Participate and help implement in the before/after CAPA process.

Participation in Internal Audits, ensuring the competency of GDP and GMP are followed accordingly to internal and external regulations.

Involved in changes made to training procedures to ensure work processes are conducted effectively and error free.

2010-2013

Intrinsic Therapeutics, Inc.

Woburn, Ma

Quality Control Inspector II

Performed inspector functions per ISO 13485 medical device quality system requirements.

Coordinated Quality Control input to purchase order submittals and documented product acceptance.

Inspected and received in-house manufactured assemblies, subassemblies and components to determine if required drawing characteristics and specifications were met.

Fulfilled inventory transactions and performed a variety of inventory control duties.

Ensured that all equipment calibration and maintenance was performed per company procedures.

Provided a variety of mechanical inspection, tooling inspection and qualification which included precision dimensional inspections and testing using calibration gauges measuring instruments and custom inspection and testing tools and fixtures.

In-process and final inspection performed in an ISO 7 Class 10,000 clean room.

Maintained Quality records and generated reports as needed.

2008-2009

NxStage Medical, Inc.

Lawrence, Ma

Complaints Specialists

Maintained daily customer complaints on a high-volume data base.

Maintained department files including complaint files and device history records.

Assist in preparation of weekly/monthly complaints quality data reports.

Gathered pertinent data for complaint investigation as assigned.

Research and maintain records of product returns for complaint investigation

2004-2008

NxStage Medical, Inc.

Lawrence, Ma

Quality Assurance

Performed incoming/in-process and final inspection on all Medical Parts, PC Boards and Disposable Components.

Reviewed and released all device history records.

Responsible for in-process and final Inspection in support of two manufacturing location.

Documentation and maintenance of inspection records including documenting inspection results in excel and perform IFS transactions.

Released all Sterile and Non-Sterile Final Products and processed samples daily to a sterilization facility before releasing final products to our customers.

Generated monthly Receiving Inspection Quality Metrics to support suppliers ratings analysis.

Maintains monthly Environmental Monitoring for clean room.

Performed Conductivity Testing on Dialysate to support release of material to stock.

Performed various testing procedures for In-process and Final Products through receiving inspection. (Equipment and Disposables). FMP manufacturing leak testing on bags and performed daily crosscuts.

Knowledgeable with the use of various precision measuring tools such as the vision system, optical comparator, calipers, micrometers, height gauges, Hipot tester and oscilloscope and other critical inspection test equipment.

Education

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Training

Member of American Society of Quality Control (ASQC)

Certified solderer in Martin Marietta Workmanship Standards

650-High Reliability Soldering

JIT and Kanban Systems

ISO9001/EN46001, and GMP’s

Total Quality Management (TQM)

Environmental monitoring, sterility, and water and bioburden testing

EN/ISO-14644 Class 7 (US Federal Standard 209 Class 10,000)

Electrostatic Discharge (ESD)

OSHA Hazard Communication Standards

Managerial Coaching and Feedback

Microsoft Windows, MS Word, Excel, and WordPerfect, Access, Oracle, Agile,SAP

Blood Born Pathogen Training

J-STD-001A(ref IPC-A-610B) Wires and Terminals

IPC-R-700C Thru-Hole Rework and Repair

ANSI/ASQZ1.4-1993 Single Sampling Plan For Normal Inspection

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