Supplier Quality Engineer

Andrea Lashbrook Horan

************@*****.***

765-***-**** (Cell)

https://www.linkedin.com/in/andrealhoran

Work Experience

Supplier Quality Engineer

Zimmer Biomet

Warsaw, Indiana

● Worked in the medical device industry, regulated by the US Food and Drug Administration (FDA)

● Supplier Quality Subject Matter Expert (SME) for European Medical Device Regulation (EU-MDR) for submissions from the following areas to the Notified Body (NB) British Standards Institute (BSI):

Supplier Quality

Contact Materials

Packaging

Part Marking Conformite Europeenne (CE) mark change management (required due to EU-MDR/Brexit projects)

Technical Writing

■ Responded to clarifying questions from the NB based on the EU-MDR submission

■ Reviewed and approved revised documents (e.g., procedure, technical specifications, prints, etc.)

● Contact Materials Project Lead for EU-MDR submission

● Team Lead for Project Utah - Response to Corrective and Preventive Action (CAPA)

Reevaluated critical-to-quality features,

Made necessary changes to the Device Manufacturing Record (DMR),

Updated prints and/or specifications,

Communicated changes to the supply base,

Gathered Production Part Approval Process (PPAP) documents,

Approved processes and documents submitted by the supply base

● Created, published, and maintained a 1500+ database of acronyms, initializations, and abbreviations, in addition to a company- and industy-focused dictionary of 1000+ terms.

● Revised Receiving Inspection (RI) documents based on Engineering Changes (NC) or New Product Introduction (NPI)

Drafted changes

Arrived at consensus

Created EC's in system

Managed approvers

Released controlled documents in the QMS and/or DMR

● Team Member for Project Polaris response to Corrective and Preventive Action (CAPA) for third-party (FDA) audit nonconformances

● Manufacturing Transfers - resourcing parts and materials

External-to-internal site (supplier-to-ZB),

Internal-to-external site ZB-to-supplier),

External-to-external site (supplier-to-supplier) Supplier Quality Engineer

Woodward, Inc.

Fort Collins/Loveland, Colorado

● Supplier Quality Engineer for current production

● 166 suppliers on four continents in ten countries for Quality, Cost, Delivery, and Responsiveness

● Guided root cause analysis with suppliers for nonconformance responses

● Set and approved PPAP requirements for external suppliers for NPI and current production

● Conducted on-site and desk audits of external supplier processes and documents Senior Auditor—Sarbanes-Oxley Act (SOX), ISO/TS16949, ISO9001 Internal Auditor Delphi Corporation

Kokomo, IN

● Internal Auditor for Global Supply Management (Purchasing and Supplier Quality) at all divisional sites

● Technical Writer for all divisional purchasing procedures and other documents

● Team member for developing corporate (GM) documents

● Single point of contact for all second- and third-party audit responses at all divisional sites Supplier Quality Engineer

Delphi Corporation

Indianapolis, IN

● Chief liaison with the Battery Business Team/Global Manufacturing

Automotive and Marine lead-acid batteries

Segway (Kaman) lithium-ion batteries

Revised User Instruction documents

Worked with Regulatory Assurance Country of Origin (COO) labelling - new and revised

Member of several contract negotiations teams

● Managed external Supplier Quality for suppliers in many varied manufacturing industries

PPAP

CAPA

Developed new PPAP process for battery label manufacturing in partnership with the suppliers

Trained suppliers on PPAP and problem-solving in six locations from New York to California and Mexico

Assisted suppliers with their Quality Management Systems (QMS) Senior Buyer

Delphi Corporation

Indianapolis, IN

● Part and material sourcing, including communicating requirements and negotiating contracts with 400+ suppliers globally

● Managed closed quote process

● Government Contracting

● Liaison between internal stakeholders, Purchasing, suppliers, Design Engineering, and Manufacturing during sourcing and resourcing

● Team member for negotiating corporate contract with single waste management supplier for Michigan, Ohio, and Indiana manufacturing plants

Project Manager: Readiness and Flawless Launch/Quality Systems Analyst Delco Remy Division, GMC

Anderson, IN

● Tracked projects to ensure flawless launches, based on risk analysis and mitigation

● Technical Writer for Supplier Quality Procedures and Work Instructions for multiple manufacturing sites Buyer - Indirect Material

Delco Remy Division, GMC

Anderson, IN

● Managed a $24 million deck of indirect materials commodities

● Saved over $2.4 million in one year through supplier negotiation, resourcing, etc.

● Divisional Purchasing representative on three corporate commodity teams geared toward drastic cost savings First-Line Supervisor

Delco RemyDivision, GMC

Anderson, IN

● Managed UAW team of 32 employees across four departments in the manufacturing plant

● Tracked attendance, gave assignments, ordered material and tools, deployed team members to other departments when necessary, tracked scrap

Education

Bachelor of Science, Mechanical Engineering

Purdue University School of Engineering and Technology at Indianapolis, Indianapolis, Indiana May 1992

Bachelor of Arts, Music Education (Instrumental, Choral, General Music, K-12), Minor in Spanish (9-12) Ball State University, Muncie, Indiana

February 1984

Languages

Spanish—conversational—speak, read, and write

Honors, Professional Certifications, and Awards

● Five years of monetary recognition awards totaling over $3000 at Zimmer Biomet

● Certified Internal Auditor

● Six Sigma Green Belt

● Delphi Corporation—Outstanding Contributions

● American Society for Quality Certified Quality Auditor

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