Quality/Project Manager

Rachael F. Shagott,

CSSGB, CQMOE, CRE, CQA, CQE

** ******** **., ***** ******, MA 02375 USA

Residence and Cell:

508-***-****; 716-***-**** E-Mail Address:

byra76@r.postjobfree.com

Summary

Business and Quality Systems Leader with strong leadership abilities in the areas of:

● Product Safety, Reliability and Regulatory Compliance

● Quality Management System development and enhancement

● Supply Chain Management of Quality and Regulatory requirements

Well versed in streamlining business processes and demonstrated achievements in new product development. Experienced in the international business arena with broad language skills. Adept at collaborating with internal and external entities to advance the organizational knowledge base. Entrepreneurial business manager with a focus on efficiencies, effectiveness and results.

Professional Experience

● Currently lead Product Integrity function supporting New Product Development Teams of Consumer Products in Mother, Infant and Toddler Feeding and Care sectors. Responsible for ISO13485 Quality Management System in support of FDA regulated Class I and Class II Medical Devices.

● Medical Device experience includes 510K , Device History Files, Risk Management (FMEA‘s & Hazard Analysis), Registrations and Listings, Customs support, and ISO 13485 Quality System Management.

● Child Care Articles experience includes New Product Development, Risk Management, FDA and CPSC Report filing and Recall Management, Standards development within ASTM F15 sub-committees and committee member of JPMA Certification Program.

Previous Experience includes:

● Launched high-level Six Sigma cross-functional team to drastically reduce product safety issues by 20% annually in Infant Toys and Baby Gear categories.

● Led Product Development efforts to achieve Safety, Reliability and Regulatory Compliance in multiple categories of consumer products including Toy and Juvenile (Child Care Articles)

● Participated in development and provided support of TSCI (Toy Safety Coordination Initiative)

● Team member for Kaizen initiatives in Environmental, Health and Safety and in Licensing business units leading to administrative restructuring and 25% reduction of process steps

● International experience in over 15 countries including 2-year international assignment in Ireland at Global Aerospace subsidiary factory and Vendor Assessments / Quality Audits in 80+ facilities.

● Led effort to assess Mexican factories for compliance to industry standards and secured major contract with International 3rd party laboratory to further develop in-house procedures.

● Served on the Global Quality Council to facilitate standardization of metrics, common practices and continual improvement throughout the global corporate community.

● Developed and implemented ISO 9001 compliant quality system for electronics manufacturing facility and instituted training programs for audit and continuous improvement.

● Contributed to accreditation of local test lab to ISO17025. Developed internal audit program.

● Initiated grassroots start-up of Licensing Industry Community of Practice (SPLiCE). Co-designed The SPLiCE Annual Licensors Workshop and launch of website www.spliceonline.com where leading licensors come together to share best practices for brand protection. Initiative resulted in an active coalition of 40+ key and Fortune 500 member companies.

Rachael F. Shagott, Page 2

CSSGB, CQMOE, CRE, CQA, CQE

Employment

Learning Curve Brands, Canton, Massachusetts 2009 – Present

Director, Product Integrity

Responsible for

Safety, Reliability and Regulatory Compliance for Mother, Infant, and Toddler Care & Feeding Products including Gates, Booster Seats, American Red Cross Safety, Health and Grooming, Variety of Class I & Class II Medical Devices including Breast Pumps and Thermometers, and Feeding line Nursery & Toddler Furniture. Compliance with 21 CFR, FDA, ASTMF963, EN71, ISO8124, ISO13485, various Juvenile Product ASTM standards, ANSI standards, JPMA certifications and various other regulatory. Responsible for management of US Vendor Quality Operations.

Fisher-Price, East Aurora, New York 1995 – 2008

Senior Product Integrity Manager

Product Integrity Manager

Responsible for

Safety, Reliability and Regulatory Compliance for Licensed and In-House Toy and Juvenile Products

Test Laboratory including ISO17025 and testing to ASTMF963, EN71, ISO8124, various ASTM standards, ANSI standards and JPMA certification

Issuance of Certifications of Compliance and Administration of the Product File

Research Library of all relevant regulatory and voluntary standards; Issuance of NEIS Summary Reports; support in development of training presentations for Product Safety Training initiatives

Led Task Groups in various special project activiteis eg Gap Analysis of Supply Chain factory Chemical Lab capabilities; Reduction of Safety Complaint; ISO17025 accreditation

Moog Inc., East Aurora, New York 1987 – 1995

Senior Quality Engineer - Motion Systems

Quality Manager - Electronics (Ireland '94)

Project Manager - ISO 9001 (Ireland '92-'93)

Quality Engineer - Space Products

Assembly & Test Supervisor - Aircraft & Missiles

Test Technician -Aircraft

Quality Management Responsibilities included QE and QC/Inspection oversight, ISO9001 QMS oversight - Management Review, Internal Quality Audit, CAPA, Supplier Quality Assurance, ITME and Calibration

Quality Engineering Responsibilities included all QE tasks related to Mil-Q-9858 QMS from RFQ thru Shipment and Failure Analysis post shipment. Included QE support of Design Reviews, Development Testing, Qualification Testing, Acceptance Testing, ABCR Reconciliation, MRB, CAPA, Supply Chain, Government and Customer Audits. Included application of Quality Statistical Toolbox techniques - DOE, Significance Tests, Regression Analysis, Process Capabilities Studies, etc

Trico Products Inc., Buffalo, New York 1982 – 1987

Inspection Supervisor - Linkages and Components

Quality Control Technician - Windshield Wiping Systems

Rachael F. Shagott, Page 3

CSSGB, CQMOE, CRE, CQA, CQE

Education

● Master of Science in Business Administration, Canisius College, Buffalo, NY, GPA 3.2

● Bachelor of Science in Industrial Technology, Buffalo State College, Buffalo, NY, GPA 3.7

● Associate in Applied Science: Industrial Technology, Erie Community College, Buffalo, NYGPA 3.8

Training and Certification

● ASQ certified: *Six Sigma Green Belt* *Certified Manager of Quality Organizational Excellence* *Certified Reliability Engineer* *Certified Quality Auditor* *Certified Quality Engineer*

● Licensor’s Workshop 2003-2008,

● ICPHSO 2004, 2006, 2010 Symposiums

● CPSC Regulatory Updates; Product Liability; Product Safety; FDA cGMP / Medical Device ISO13485; ISO17025; Mattel International Management Program / Managing Across Cultures; LIMA Licensing University; Conflict Management; Diversity; Legal Aspects of Management; Team Building; Reliability; Statistics / DOE; ISO 9000

● PC Proficiency – MS Office Suite, MS Project, MS Outlook, Visio, Various Statistical Analysis packages, Web-based applications

Facilitation & Training

● JPMA Certification Committee 2010/2011; ASTM F15 Sub-Committees 2009/2011

● Learning Curve Brands Quality Summits (2009, 2010) - Chair

● ASQ CRE Exam Chair 2007/8; RD Liaison 2005/6, ASQ Exam Review Committees 2000/10

● Panels –

Licensor’s Workshop 2003-2008;

LIMA Licensing Show 2005;

ICPHSO 2004 & 2006 Symposiums

● Mattel Quality Summits (1996-2008) – Best Practices & Lessons Learned

● SPLiCE Annual Workshops (2003-2008) – Best Practices & Lessons Learned

● China Factory Vendors (1996-2010) – ASTM Standards, Product Safety, Process Control, Cpk, MOSS, Test Methods

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