Supplier Quality Management

Contact:

Eke Okeke

Cell Phone: 978-***-****

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

EKE J. OKEKE

SUMMARY:

Supplier Quality Leader & Leadership position in supplier quality and/or commodity management with strong background in manufacturing/supplier quality environment, continuous improvement, and application engineering.

Provide leadership in supplier quality engineering and customer satisfaction with solid understanding of GCP, GLP and cGMP quality systems.

Plans, organizes, directs, and reports on all supplier quality-related activities relative to raw materials, contracted designed and manufactured items, packaging materials, OEMs, distributors, and laboratories to assure 3rd party providers meet or exceed requirements for medical device and Pharmaceutical Products.

PROFESSIONAL EXPERIENCES:

Lantheus Medical Imaging, Billerica, MA Jan 2022 – Present

Manager Supplier Quality, Supplier Quality Management

Manages CMO Suppliers to support NPI and sustaining projects and ongoing supplier quality management activities.

Prepares, maintains, and reviews Supplier Quality procedures to assure compliance with customer and local, state, federal and international regulations.

Actively supports management and resolution of key issues which impact product release at CMOs

Review deviations, supplier change notification, (SCN), SOP procedures, CAPA, and reports to ensure compliance to internal and GMP standards.

Support weekly MRB meeting to review non-conforming materials and manage and issue SCARs where applicable.

Conduct API and CMO Suppliers ISO 13485-2016, ISO 9001-2015, and cGMP audits as a Lead Auditor.

Write Complaint and Production SCARs and analyze root causes and corrective and preventive actions.

Support Supplier Deviation Investigations, change controls and supplier changes resolution management.

Leads Lantheus Material Review Board (LMRB) to ensure supplier changes are managed effectively and efficiently.

Draeger Medical Company, Andover, MA Aug 2018 – Nov 2021

Senior Supplier Quality Engineer, Draeger Supply Chain & Purchasing

Managed OEM Suppliers to support NPI and sustaining projects and ongoing supplier quality management activities.

Support Process validations (VMP) and Qualification plans to support revalidations and relocation projects as a core team leader.

Managed second sourcing activities to domesticate supplier base.

Support weekly MRB meeting to review non-conforming materials, and MRB aging report and issue SCARs where applicable.

Conducted OEM Suppliers ISO 13485-2016 and ISO 9001-2015 audits as a Lead Auditor.

Write Complaint and Production SCARs and analyze root causes and corrective and preventive actions,

Developed FAI plans, execute FAI results, and determine inspection plans and document FAI package.

Managed no problem found(NPF) resolution with top key suppliers. Working with Design Engineering and Supplier to drive issues to resolution,

ABIOMED INC., Danvers, MA Sept 2017 – Aug. 2018

Senior Supplier Engineer, Abiomed Supply Chain & Procurement

Managed Plastics Suppliers to support NPI and life cycle management products.

Supported life cycle management and NPI projects as a core team member leading supplier and material selections, qualifications and supporting process validations.

Managed second sourcing activities to domesticate supplier base.

HOLOGIC INC., Marlborough, MA June 2014 – Sept. 2017

Senior Quality Engineer, Diagnostics (Thin Prep)/Surgical Manufacturing

Managed/processed Diagnostics Suppliers’ non-conforming materials and SCARs issues

Managed and coordinated timely Diagnostics Supplier SCARs responses and effectivity

Chaired weekly MRB meeting to review non-conforming materials, and MRB aging report

Managed Commodity Teams review meeting to review supplier quality issues, quality ratings, and monthly quality review

Led new supplier qualifications and on-site assessment process

Managed and maintained overall supplier quality performance, quality ratings with emphasis on reduction of the nonconforming products issues

Conducted Supplier ISO 13485-2003 and ISO 9001-2008 audits as a Lead Auditor.

PHILIPS HEALTH CARE, Andover, MA Jan 2003 – June 2014

Senior Supplier Quality Engineer, Material Management Group

Managed major cable assembly’s supplier and single point of contact for resolving quality issues, quality ratings, and monthly quality business review

Chaired weekly MRB meeting to review non-conforming materials, inventory cost, and MRB aging report

Led Ultrasound business team in developing and implementing a global single crystal strategy for transducer manufacturing

Managed overall supplier quality performance, with emphasis on reduction of the nonconforming products issues

Managed and maintained several Transducer suppliers’ quality ratings and monthly review performances

Led a supplier strategic team on new supplier qualifications and on-site assessment process

Conducted Supplier ISO 13485-2003 and 9001-2008 Audits as a Lead Auditor

Led Ultrasound team in developing Flex Circuit assemblies’ global strategy and its implementation

Led Transducer team in developing a startup company to become a major production supplier for Philips Healthcare single crystal products

PHILIPS MEDICAL SYSTEMS, Andover, MA Dec 2002– Jan 2003

Senior Commodity Manager,Strategic Procurement Management Group

Managed a $40M spend on major mechanical cart assemblies; contract manufacturer power supplies; Commercial off the shelf (COTS) hardware PC, sheet metal and tooling

Acted as Ultrasound business line lead person to support Philips Medical corporate-level purchasing strategy in the development of mechanical assemblies; power supply; and sheet metal commodities

Developed tooling strategy for Ultrasound team and identified a 40% cost savings in sourcing

Led effort in initiating a 5% year over year cost reduction plans with our strategic suppliers

Commodity Manager/Procurement Engineer, Global Material Management Group Mar 2001 – Dec 2002

Managed plastics, castings, and machining parts and assemblies and $20M material and tooling spend

Led a team to develop Plastics Strategy for Global CMS business line

Provided design for manufacturability (DFM); design for assembly (DFA), and vendor/material selections to NPI to enable successful releases of major Transducer and Ultrasound products

Led a cross functional team to resource major commodities to cost effective suppliers enabling double-digit productivity and no line interruptions

Reduced Plastics and Machining supplier base to allow us to leverage spend

Developed process to manage obsolescence components at the supplier base

XEROX CORPORATION, Webster, NY

Global Tooling Sourcing Manager,Global Production Purchasing Organization Mar 1999 – Mar 2001

Managed a $35M corporate tooling spend

Developed tooling sourcing and management strategy and directed the work of professional staff on the tooling team

Developed a worldwide benchmark tool supplier base to leverage the participating companies tool spend

Managed resourcing of tools/fixtures from underperforming Plastics suppliers to alternate suppliers; the tool moves activity yielded double digit productivity and no line interruptions

Plastics & Elastomer Commodity Technical Manager,Product Comm. &Operations Group Jan 1992 – Mar 1999

Provided short/long term technical vision and project planning

Championed cost down initiatives/implementation; facilitated cost down workshops

Led Plastics Mexican Suppliers’ development Project

Supported SE Asia Supplier development project. Enabled sourcing of small/medium size parts and complex assemblies

Acted as technical interface to our vendor base in problem solving and cost down opportunities

Championed business resumption planning, implementation, and auditing for compliance

Manufacturing Planning & Technology Group Oct 1990 – Jan 1992

Senior Technical Specialist– Plastics

Provided manufacturing resource base to disseminate the latest ready technologies across product lines.

Led a team that established acquisition of plastics prototype parts through Xerox production supplier base. Developed plastics prototype matrix.

Led Plastics Mexican Suppliers’ development Project

Introduced lunchtime University program to bring timely topics to design engineering communities. Coordinated design for manufacturability studies.

Advanced Materials and Manufacturing Technology May 1986 – Oct 1990

Sr. Project Engineer

Provided plastics technical support to product design team by recommending materials, tooling and process methods, and design to reduce cost, timely part delivery, and reliability.

Global support of early and continuous supplier involvement (ESI & CSI) on all programs.

EDUCATION

University of Lowell

BS Plastics Engineering

Graduate Studies in Plastics Eng.

Roxbury Community College

AS Physical Sciences

PROFESSIONAL AFFILIATIONS/AWARDS

Coached Youth Soccer (2014 – 2018)

Recipient – 02 U.S patents and 02 U.S. patent applications

Senior Member - National Society of Plastics Engineer (Present)

Xerox Achievement Recognition Award (1999, 2000, 2001, 2002)

Speaker - Society of Manufacturing Engineers (1997)

Recipient - New Product Design Competition Award at SPI Structural Conference (1997)

Xerox Team Excellence Award (1997, 1999)

Member - Xerox Plastics Remanufacturing Recycling Steering Committee (1997 - 1999)

Speaker - Society of Plastics Industry Structural Plastics Technical Conference (1997, 1999)

Chairman - Xerox Division United Way Campaign Appeal (1998)

SKILLS/TRAINING

Purchasing & Quoting of Plastics Parts, Dimensioning Concepts Series, Plastics Part Design Seminar, Management Studies Program, Life Orientation (LIFO) Training, Project Management, Lean Manufacturing, Green Belt Training, APQP (PPAP, FMEA, CP, Process Map), ISO 13485-2016 & ISO 9001-2015 Lead Auditor

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