Quality Assurance

DIANE SHAY

Home: 978-***-****

** ******* **. **** *** Cell: 978-***-****

Billerica, MA 01821 *****.****@*****.***

PROFILE

Talented and accomplished quality management professional with expertise in quality system compliance with ISO13485/21CFR820-QMS Medical Devices, AS9100-Aerospace QMS, ISO14971 RM-Medical Devices, cGMP, GLP, MDD, CMDD, and PAL. Adept at developing and leading multi-functional teams, improving processes, and meeting organizational goals. Consistent record of contributing to revenue growth through support of continuous improvement projects and new product development.

• Quality System Development • New Product Development

• Supplier Quality Management • Program Management

• Post Market Surveillance • Inspection, Laboratory Testing and Document Control Supervision

PROFESSIONAL EXPERIENCE

HAEMONETICS CORPORATION, Braintree, MA (2010 – 2011)

Director Post Market Surveillance

• Managed corporate complaint department and CAPA, performing over 40 health risk assessments and oversight for recall documentation

• Led development of global complaint management and post market surveillance program incorporating Oracle and Agile interface as well as software and quality system training programs

• Directed quality engineering support for $15M in cost improvement projects and two new product development platforms, including supplier qualification

• Established site and corporate quality review boards and metrics

• Developed root cause and corrective action training workshops, templates and testing

• Managed staff of 12 quality engineers, complaint managers and coordinators

ACCELLENT CORPORATION, Wilmington, MA (2007 – 2010)

Director / Principal Quality Assurance

• Directed global document control and regulatory affairs, supporting 13 facilities

• Program manager for corporate-wide system improvement projects for sterilization, manufacturing transfer, environmental monitoring, design control, validation, process control, non-conforming material control and risk management, reducing customer and ISO audit observations by 20%

• Led development of corporate and site management review templates, as well as associated metrics and goals

• Maintained global site registrations/inspections in order to comply with FDA, MDD, CMDD, ISO13485, and AS9100

• Coordinated development of facility inspection preparation plans and responses

• Negotiated over 30 customer and supplier quality agreements

• Led initiatives to resolve customer systemic product and quality system issues

• Managed staff of 5 quality engineers, inspectors and document control coordinators

Diane Shay Page 2

INSULET CORPORATION, Bedford, MA (2006 – 2007)

Associate Director Quality Assurance

• Directed plant inspection, document control, supplier and plant quality engineering

• Led development of supplier rating program using QAD software

• Responsible for clean room and sterilization validation as well as routine monitoring

• Managed staff of 9 quality engineers, inspectors and document control coordinators

MILLIPORE CORPORATION, Bedford, MA (2005 – 2006)

Senior Corporate Quality System Manager

• Directed biopharmaceutical corporate design assurance and document control

• Led change notification, promotional literature control and design control system improvements, incorporating Kepner-Tregoe Project Mgt. and WPI certification program

• Maintained stability program, drug master files, and animal origin declarations

• Managed staff of 6 quality engineers, system and document control specialists

ACMI CORPORATION, Southborough, MA (2002 – 2005)

Senior Manager Corporate Quality

• Developed programs for SPC, validation, risk management, good documentation practices, lab notebook control, design control, complaint and supplier management

• Centralized biocompatibility and stability testing and managed databases/testing

• Managed two quality engineers, supporting design assurance and supplier quality

ATRIUM MEDICAL, Hudson, NH (1997 – 2002)

Quality Engineering Manager

• Coordinated preventative maintenance, calibration and manufacturing trend reporting

• Developed programs for validation, design control and supplier management

• Reduced inspection costs and improved mfg. capacity using DOE/six sigma to eliminate inspections, dock to stock programs and roving inspections to replace batch inspection

• Managed two quality engineers, supporting design, manufacturing and supplier quality

MEDTRONIC IP, Danvers, MA (1996 – 1997)

Sr. Quality Engineer

C.R. Bard, Billerica, MA (1983 – 1996)

Quality Systems Supervisor/Sr. Quality Engineer

EDUCATION

MS Quality System Management – Six Sigma Concentration, National Graduate School

Thesis: Development of on line Supplier Quality Manual

BS Medical Technology, North Adams State College

TECHNICAL SKILLS

MS Office, MS Project, Visio, Minitab, Design Expert, Statgraphics, Oracle, QAD, Agile, Pilgrim

ADDITIONAL INFORMATION

Board member of New England Biomedical Discussion Group, a Division of ASQ

Seminar speaker for Validation Statistics, Risk Management and Design Control

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