Ronald H. Lee

ac17h3@r.postjobfree.com

*** ******** *****

Morgan Hill, CA

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

Selected Accomplishments:

Identified and drove $1.8 million cost savings during initial ten months at Boston Scientific by processes improvements, and working with R&D incorporating product design changes. Shrunk supply base while staying on AVL.

Expertise: Lean and Six Sigma, Process Improvement, Material Procurement, Agile PLM & Agile PPM, Supply Chain, Oracle, SAP PPM, Clarizen, Value Analysis, Product Verification & Validation, Track Wise, CAPA, Material Program/ Project Management, Quality Systems Remediation, In-Vitro Diagnostics/Medical Devices, and Documentation and Control, cGMP experience and cGMP and compliance.

Five years as Part of Design Teams from product inception through commercialization. Located, audited, and certified supply chains, which are FDA 13485 & 21 CFR Part 11, Conflict Materials,

and RoHS Compliant for Product Development Roadmap.

Provided technical, Lean Sigma, and Business Support for cross -functional teams for Value Improvement Projects & Products (VIPs), RFQ/RFPs, Procurement, Verification & Validation, supplier selection assessments, and NPI support.

Education

Master of Business Administration (MBA) (Bus. Admin. & Fin.) Golden Gate University

Bachelor of Industrial Engineering (BIA)Kettering University (General Motors Institute)

PROFESSIONAL EXPERIENCE:

Thermo Fisher Scientific, Sunnyvale, CA

Environmental Compliance Manager /QS Project Coordinator (Consultant) March 2015 – July 2017

Responsible for the coordination of CAPA Program including initiating CAPAs, ensuring timely

completion of CAPA activities, and providing adequate quality review/assessment of CAPA closure activities.

Worked directly with the Quality staff to ensure that deliverables for CAPA closure are completed in a

timely manner. Created and Presented Status reports on CAPA trending activities to management.

Comfortable “chasing down” the proper stakeholders to ensure closure and timely completion of CAPA activities. Familiar with ISO 9001: 2008 Quality System. Strong interpersonal skills, problem-solving skills, planning/organizational/strategic skills, and a customer-focused philosophy. Reviewed CAPA planning processes and ensured adequate CAPA investigations & Root Cause Analyses were performed. Ensured Corrective Action has taken place and preventive action measures have been implemented. Provided quality review and assessment of CAPA closure activities Regulatory Guidance documents and cGMP and compliance.

Status the ECNs and ECO of those policies and procedures to link those to the QMS. Drove activities such as tracking project deliverables/timelines, gathering and managing project metrics, and providing status updates and presentations to upper management impact to build status. Reviewed documentation, and helping with possible creation/editing of documentation when necessary. Provided cross-departmental communication and coordination, and drove communication.

Accountable to the Business Unit’s compliance to RoHS, REACH, WEEE and applicable environmental product regulations as they emerge. Managed component engineer and supplier.

Researched and interpreted the regulations, directives and applicable laws and provided practical guidance

to Management, R&D and Operations teams to establish and maintain compliance to ISO 9001:2015.

Worked with R & D on Neptune NPI to assure electronic and mechanical electrical components complied to RoHS, REACH, WEEE to proto-types components Regulatory Guidance documents and cGMP and compliance.

Maintained prioritized build plans and schedules for Neptune NPI components met RoHS, REACH, WEEE and applicable environmental product regulations as they emerge, and provided reporting for management, including progress, risks and mitigation recommendations. Updated NPI BOMs (depending upon proto-type configuration) with material status from suppliers on component prior to each proto-type build. Assessed new components and sub-assemblies from supplier’s documentation (Jabil Circuits) and emerging requirements and recommended compliance strategies to management to avoid disruptions.

Established and maintained overall compliance strategies for the business unit.

Worked to maintain awareness of applicable standards and regulations; interpreting and reporting impact

on the business unit with risk based recommendations.

Interfaced with outside agencies to maintaining current and future compliance status, communicating internally and proactively lead cross functional projects to meet regulatory requirements.

Janssen J & J Fremont, CA

Senior Program Manager (Contractor) January 2015 – Sept 2015

Procurement-based competitive advantages. Developed and managing of sourcing for material prototype analysts and by providing category analytics & metrics.

Developing partnerships with Category Directors enabling global analytics across all category strategies. Assessed current supply base, identified operational requirements, and negotiated strategic supplier procurement agreements.

Managed team of three analyst(s) to include performance management and adherence to all policies and procedures. Supported Supplier Relationship Management processes by providing content, managed logistics and day-to-day escalations and worked with two functional drug formulation development teams on supplier verification and validations at two Janseen sites. Developed Supply Score Card and corrective action plans to improve metrics and category strategy. Proactive contract expirations and renewals including the development of negotiation and agreement strategies. Conducted root cause analysis and develop corrective action plans for mismatches, invoice-in-hand, use of non-preferred suppliers, and increase spend with diverse suppliers.

Hospira, Inc., San Jose, CA

Program Manager (Contractor) August 2013 –September 2014

Accountable for management of programs from concept through launch and responsible to ensure the teams are on track following approved product develop, change, and quality plans.

Assists in developing strategies for specific product lines.

Provide project leadership on cross-functional team of supply quality engineer, buyer, and compliance professional defining clear, realistic goals; clear barriers to ensure team progress,

and facilitate rapid decision-making.

This includes the following:

oChange Management and Risk Assessment Plans and FMEAs.

oProduct CAPA Product Resolution and Closure.

oOwned CAPA’s for three different products/manuals and remediated 483 from moving production from US to Costa Rica Regulatory Guidance documents and cGMP and compliance.

oIdentify and delegate action items, follow-up/track action items to resolution, update project

plans & deliverables, an, as required, identify and resolve issues off-line.

Assure completeness and accuracy of project Design History Files.

This includes coordinating/auditing product documentation to ensure compliance and product quality, CAPA RCCA, Resolution and Closure Manage project timelines, budgets, and risks

(Agile & Microsoft Excel and Project).

BOSTON Scientific, BSC, San Jose, CA

Materials Project Management (Promotion) September 2011 – March 2013

Lead programs and projects via Materials Department with a focus on NPI (New Product Introduction), improving supplier quality, procurement, prototypes, and performance. Developed and drove Value Improvement Projects (VIPs), Supplier Development Projects, manage). Determined CM capability to meet component and/sub-assembly project cost and budget targets and to produce released designs and negotiated requirements with marketing, and engineering to develop long-term product procurement strategy.

Interface with R&D on material procurement, (Electro and Electro-Mechanical) cross-functional teams, managers, and senior management to meet project build and release milestones, and deadlines.

Supplier Development

Supplier Audit and Qualification cGMP experience.

Managed high-risk materials team of supplier quality engineer, process, plastic, process engineer and two product inspectors. Facilitate and managed supplier verification &validation, senor prototypes,

and qualification for new prototypes and component suppliers for PLM. Assembly break down (reverse logistics) to determine component suppliers, carriers, ports of entry, & exit, Harm Codes, and shipping costs Regulatory Guidance documents and cGMP and compliance.

Planned, managed, and scheduled material for prototype builds (inventory management in SAP); collaborate with internal groups such as Procurement, Supplier Quality Engineering, Logistics, Finance, Manufacturing Engineering, Component Engineering and Quality Engineering.

Product & Technology Development

Direct team activities, establishing task priorities, scheduling, sensor prototypes, and ensuring the availability of resources and determined addition spare components for proto builds and warranty spares.

Daily inputs from SAP log file from field engineering and field sales for released products per doctors and clients in the US and EU. A Patient sequence number, client /doctor name and location, item name, part number, implant date, and issue.

RMA items when received are examined and information is fed back to R&D and Manufacturing Operations.

Inputs in Clindex for EU and US open and blind clinical trials.

The issues are examined to determine which are product designed related or manufacturing process related. Information is fed back to R&D and/or Manufacturing Operations.

All information is tracked and maintained in a data base and summarized weekly, monthly, quarterly, and annually.

Lead and provide supplier development support to develop new process technology and ramp of new product development (PLM) (Clarizen) projects.

Commodity Team Support

Provided technical and business support to Value Improvement Projects (VIPs), RFQ/RFPs, supplier selection assessments, senor prototypes, and NPI support.

Value Add and Principle Sigma Supply Engineer February 2009 - 2011

Engaged Plant Value Stream operations to identify and implement cost reduction opportunities, senor prototypes in materials as they related to supplier rationalization and upstream or outsourcing transfer of material to suppliers.

Knowledge of quality related tools including, but not limited to, Root Cause Analysis, SPC, Gage R&R, FMEA, and Clarizen.

Managed cross-functional teams in the executing critical supplier improvement/cost reduction initiatives.

CAPA against suppliers for V&V. Did supplier audits, did V&V on supplier processes to close out CAPA’s related. Looked at SCAR’s NCMR’s. Did root cause and RCCA on those CAPA’s and closed.

Principle liaison between product development, quality engineering, CAPA, SCAR, NCMR, RCCA

through CAPA Closure. Production, marketing, field service, and suppliers to assure specifications, acceptance and testing criteria clearly identified, documented and agreed to by all parties.

APPLE INC., Cupertino, CA 2005 – 2009

Senior DFX Engineer

Mechanical design for “everything”: manufacturability (DFM).

Serviceability, testability, managed team at Foxconn supplier consisted of three quality inspectors, 12 assemblers, four ME’s, two process engineers, and four buyers.

DF(x) where ‘x’ is any variable)! Evaluation of product designs.

Qualification and audit of suppliers.

Analyzed design for manufacturing processes and procedures, cost reduction and quality. Planned,

developed NIP schedules (PLM), created assembly planning, and design fixtures for assembly.

Provided technical support to suppliers and processing suppliers. Directed purchasing of tooling and fixtures to support assembly operations.

Provided technical and processing SPC (Statistical Process Control) support to suppliers.

Leveraged quantitative data, CPK/PPK & SPC techniques as basis of input for product design

Changes, mfg. and improvement. NPI support throughout all phases of PLM.

Monitored and analyzed EM internal (Electro and Electro-Mechanical) performance data to score per ISO Standards (ISO 9001).

Assessed supplier for Select Supplier Program (SCM). Developed supplier quality control policies

and AQL sampling plans. Identify and analyze EM cost variances to determine RCCA.

MOTOROLA, INC., San Jose, CA 2004 - 2005

Product Quality Engineer (Contractor)

Transition products from assembly and test at Motorola-BCS, to an EM (external manufacturer), managed a complete “box build” (Electro and Electro-Mechanical) at supplier which included supplier three quality inspectors, 8 assemblers, two ME’s, process engineer, and two buyers. Qualification and audit of suppliers.

Managed day-to-day manufacturing engineering operations activities.

Managed EM to quote on and off AVL suppliers with qualification plans as required.

Negotiated requirements with product marketing, engineering, customers etc. to develop long-term product supply strategy. Quote product assembly and test (manual, ICT, AOI, and functional testing), developing and implementing supplier product quality triggers, metrics, and supplier score carding.

Reviewed all product engineering documents, BOMs, and ECOs’ (Engineering Change Notices) and procurement for impact on inventory and implementation.

Experience with product compliance regulations (e.g., EU RoHS, EU WEEE) and industry standards.

Defined test plans with design engineering, coordinated regulatory testing, certification effort and maintained certification records.

SUN MICROSYSTEMS, INC., Newark, CA 1997– 2003

Supply Product Manager

Managed continuous improvement of technical aspects of CQAT Cost, Quality, Availability, and Technical).

Functional team included supply quality engineer, buyer, four assemblers, and a quality engineer.

Assembly break down (reverse logistics) to determine component suppliers, carriers, ports of entry, & exit, Codes, and shipping costs.

Maintained metrics for process improvement, supplier management, and management.

Approved technical aspects of supplier evaluation, material component qualification, EM quality report card, and defined and implemented product quality goals. Qualification and audit of suppliers.

Verification & Validation, Qualification and audit of suppliers.

Extensive NPI support throughout all phases of PLM at EM (Suppliers).

Managed and drove the development, implementation, and reliability testing of repair processes at

EM Celestica.

Conducted quality (MIL, AS, and ISO) and manufacturing surveys to secure on time quality product.

Experience with product compliance regulations (e.g., EU RoHS, EU WEEE) and industry standards.

Supply Project Engineer

Managed engineering initiatives from phase development life cycle (PLM) per engineering standards.

Managed supply chain cost, quality, and availability of commodities (inventory management in Oracle), and services procured from the supply chain including distribution planning, production planning (Electro and Electro-Mechanical), procurement simulation, customer communications and product forecasting.

Demand planning in a multi-step operational supply chain management (SCM) process used to create reliable product forecasts.

Experience driving product compliance to regulations (e.g., EU RoHS, EU WEEE) and industry standards.

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