Julie Williams Email and Phone Number

• Qualify equipment for testing and pad printing processes – write protocols, coordinate execution activities, and analyze data and write reports.• Create Test Method Validation plans, direct personnel during execution, analyze data and author subsequent reports.• Create Change Notifications and created project plans/ managed resulting projects:o Determine the level of change (minor, moderate, or major)o Assign a team relevant to the change being proposedo Determine impact of the change to all areas/systemso Plan action items based on impact assessment, prepared a project plan and assigned responsibilities to either myself or appropriate personnelo Track completion of action items, and coordinated efforts to complete action itemso Coordinate training as needed• Create new and update manufacturing documents and product / process specifications.• Reach out to suppliers to resolve problems/issues that impact the ability to implement changes and process improvements and jointly work out a solution

• Assisted CAPA owners of aging CAPAs in proper completion of all CAPA phases, including root cause analysis, determined what actions needed to be taken and the required deliverables in order to bring CAPAs to completion, and ensured completion in a timely manner.• Completed a CAPA relative to Supplier qualifications from identifying CAPA scope through completion, resulting in Supplier re-classification and update to ASL Some phase actions include:• SAP upgrade to S4 HANA, meeting the go live implementation date: Prepared all calibration related/gauge data and metadata, including such information as standards, tolerances, calibration intervals, calibration (PM) instructions for transition of calibration data from GageTrack to S4 Hana, utilizing excel, organizing the data in such a way to correlate to the database structure configuration/logic of S4 HANA calibration portion of QM module for the S4 HANA implementation team to upload. • Performed internal audits in the capacity of lead auditor, which included verifying any previous audit findings have been addressed successfully.• Maintained weekly and monthly quality metrics.• Created and also provided guidance relative to quality related risk analysis activities.• Ensured compliance of change requests identified in audit findings as well as other open/aging change requests by defining requirements, developing or updating action plans as warranted, and execution of all activities in accordance to procedures and requirements.

• Managed the NCR and CAPA systems, including creating metrics for weekly and monthly management meetings.• Performed investigations to determine root causes of nonconformances, and dispositioned nonconforming material• Authored rework instructions for nonconforming parts as applicable.• Verified risk coverage of nonconformances to determine whether a new risk needed to be added or existing risk(s) addressed the nonconformance(s).• Evaluated effectiveness of corrective actions for CAPAs; collected and analyzed data and documented the results in effectiveness check reports• Performed DHR reviews and label content reviews before release of product into inventory

• Created User Requirements specifications, Validation protocols and Reports for Software Validation specific to GxP software (MeasurLink upgrade), manage the executions of the protocols and authored the validation reports• Completed Data Integrity Assessments for the Metrology equipment software/measurlink interface and handling of GxP data, identifying gaps and recommending solutions. • Provided support and assistance in clearing up the Customer Complaint backlog.• Participated as a team member in a Kaizen event specific to addressing material variances of a component

This project has 3 phases: Determining scope of CAPA, Performing Gap Analysis of DHFs against the NPI procedure, and remediation of the gaps. Product in the Consumer business potentially has not been released properly in AGILE from NetSuite and actively being sold.  Spearheaded the task of determining, with a cross functional team comprised of Sales, Marketing, Product Managers, and DQEs, which items sold in the consumer channel are to be in the CAPA scope, and with a cross functional team, actions to be taken for items needing to be removed from Consumer sales channels, delegated to the appropriate project teams for execution Engaged with cross functional teams to determine corrective actions and generate deliverables for the gaps and ensured deliverables were completed on time meeting the project schedule. Performed a gap assessment of DHF deliverables released in Agile to the product release process requirements for items actively being sold in Consumer sales channels to determine if all design and regulatory requirements were met prior to product release Partnered with Design, Quality, Regulatory, Product Managers and Suppliers (when required) to determine and initiate corrective actions/remediation to address any gaps or data inconsistencies in DHF files or retrospectively build DHFs as needed. Verified data accuracy between NETSUITE and AGILE to identify products that were released in AGILE properly but don't cross reference properly  Created gap analysis template

  Analyzed the data flow of electronic and recorded data against the ALCOA principles and 21CFR11 for Filling, Overwrap, Sterilization and packaging processes  Created Data Integrity risk assessments based on data integrity gaps, evaluating the criticality and availability of data needed for Product Release to make a decision to release product Evaluated the CPPs and CQAs required to be documented on manufacturing documents based on equipment validations, system specifications, equipment and functional specifications for Filling, Overwrap, Sterilization and packaging equipment and processes, documenting inconsistencies beween all of the documents when applicable Recommended interim and long range corrective actions for each data integrity gap Evaluated effectiveness of implemented interim actions  Performed gap analysis assessment of B Braun Irvine’s procedures against EU GMP Annex 1:2017 draft requirements

 Led cross functional teams to review supplier change requests, determine and coordinate deliverables action plans with the supplier and Medtronic, and evaluate results for acceptability to implement change. Initiated contact with component suppliers and jointly led effort with the SQE of facility in Mexico to integrate portions of the supply chain to minimize import and export costs and reduce lead times. Collaborated on and approved component qualification protocols and documentation, and inspection plans authored by sister facility in Mexico. Assisted Medtronic regulatory in Korea by obtaining documentation and information required by the Korean notified body for the technical dossier, resulting in submission two weeks prior to the deadline and avoiding an audit.

Reviewed customer complaints and investigations to verify risk coverage, determining if escalation is required and recommended when new risks need to be added and to which risk documents. (Risk documents include Device System risk analysis, Software risk analysis, Mechanical and Electrical DFMECAs, PFMECAs, and component DFMECAs for pacemakers, leads, catheters and accessories, telemetry issues, patient monitoring and programming systems) Identifed missing risk documents across multiple facilities, and aligned the existing risk documents to remove duplicity and standardize. Updated all Lead, packaging, and sterilization PFMEAs to align with the FDA coding system relative to hazards, hazardous situations, and harms (FMECA format)

 Led all product validation activities and coordinated with tooling engineering for new mold validations relative to Medtronic Surgical development projects, including authoring protocols, data analysis and writing reports Created control plans, PFMEAs and inspection acceptance criteria for product involved in the Medtronic projects Participated in a continuous improvement project to streamline the packaging process and reduce costs Partnered with the senior metrologist to help troubleshoot any problems, when revealed by analyzing poor Gage R & R results, with CMM fixtures or programs related to the Medtronic development projects Audited DHRs for accuracy and GDP As needed, performed final product inspection audits

 Authored Product Validation protocols, organized execution, analyzed data, and summarized results in reports for development projects Assisted a European customer, applying for the CE mark to become a European distributor of a Xeridiem product family, to assemble a technical dossier file per requirements of the EU notified body. Directly interacted with customers relative to 90 day notifications and specification requirements, implementing changes, authoring notification letters and providing support to customer requests. Developed fixtures and provided support in root cause analysis for suppliers that had quality issues Performed internal audits Created test procedures and work instructions Provided support and guidance to assist manufacturing continuous improvement projects and scrap reduction strategies

Short term contract position for remediation: Analyzed content of Quality Notifications(NCRs) for accuracy, determining if root cause has been defined, and material has been quarantined/dispositioned including gathering physical evidence that the material was contained and dispositioned per the transations made in SAP  Verified that GDP had been followed, cross-checked the documented information in the QNs against procedures to determine procedures were followed correctly and all required information was present Audited the corrective and preventive actions, verifying they had peen performed and collaborated with operators, engineers and other functions to address and correct inaccuracies.

 Developed and executed validation protocols, creating final reports for equipment and process qualifications.  Played a key role in successful qualification of specialized software created to track serial numbers in hexadecimal format to prevent duplicate serial numbers on units from release to medical device customers.  Developed software validation protocols and final reports, resulting in positive customer comments in areas of detail, organization and thoroughness as noticed during audits.  Led and directed activities of cross-functional teams to create FMEAs for new products.  Managed CAPA teams in the determination of root causes and the development and implementation of corrective action plans in response to SCARs.  Composed work instructions, assembly reference documents/schematics, inspection plans and manufacturing area-specific standard operating procedures.  Initiated investigations to address production issues, customer complaints and warranty RMA returns.

Assignments - Special process validations and supplier part qualificationsResponsibilities:• Conducting validations (IQ/OQ/PQ) at suppliers for welding processes and Printed Circuit Board fabrication ( Soldering & Assembly) processes and provided guidance to the suppliers to develop and implement effective process control techniques among which includedo Analyzing and validating the capability of the measurement systems being used for repeatability, reproducibility, and when historical data was available, the stability over time o Creating and utilizing Process and Product FMEAs, control plans, control charts, and sampling plans to analyze, control, and improve product quality • Provided assistance to welding suppliers to meet the requirements of AWS D1.1/D1.1M:2002 to qualify non- prequalified welds which involved creating Weld Process Specifications, preparing test coupons, visual inspection and destructive testing• Interfaced with Engineers, Buyers, Suppliers, supply chain, and commodity managers to resolve quality, design and procurement issues• Performed first article inspections as needed at supplier sites for components that required welding and plating special processes when suppliers did not have enough manpower to complete in the case of a large quantity of FAIs needing completion against an aggressive schedule• Confirmed components supplied to Philips specified to be ROHS compliant have met the requirements and proper documentation • Ensured suppliers demonstrated readiness to manufacture production parts using agreed process criteria and controls as per the Philips Supplier Part Qualification (SPQ) process • Verified that personnel performing the special processes were properly certified as per the requirements specified in the applicable industrial standards and guidelines

Responsibilities included:• Developed and executed protocols and test plans to validate equipment and processes, analyzing the results using methods such as statistical models, capability studies, measurement system capability (Gage R & R) • Partnered with operators to improve existing work instructions and create detailed work instructions for specific critical processes• Provided support, as a member of a cross functional team, in the management of a battery life extension/labeling project for Lithium ion batteries which included relabeling per EC ROHS standards and FDA requirements, shipping of the batteries domestically and internationally, and proper disposal of the batteries• Authored PFMEAs as part of an integrated team, reviewed Software FMEAs, and actively participated on cross functional design teams updating/revising DFMEAs and AFMEAs to analyze, control and improve product quality • Conducted initial audit to assess Quality System and process capabilities of a test lab, resulting in the lab becoming a new supplier • Revalidated outside special process suppliers relating to ETO sterilization and bioburden testing processes• Evaluated failure investigations that had been driven by customer experiences • Analyzed nonconformities to characterize causes as routine (common) or exceptional as a member of the MRB (Material Review Board)• Assisted CAPA owners in determining root cause, creating corrective and preventive action plans and analyze results of implementation to determine if further action was needed

Contract Product Engineer (through InfoTree Services)• Process development and product design input of development projects for assemblies comprised of injection molded componentso Qualification and validation of subassemblies used in medical deviceso Process characterization and process improvements for components and subassemblieso Develop test method protocols and Master Validation Plans Perform gage R&Rs to assess and improve dimensional and attribute inspection techniques Improved in-process inspection accuracy of molded components by utilizing the Smart Scope for measurements instead of a toolmaker’s scope. R&R results improved from 76% to 7% (Minitab scale-the higher the %,the worse the results)o Capacity planning and analysis, design for manufacturability, transfer of design to manufacturing.o Establishing BOMs and setting up process routings, costs, and data collection in ERP systemo Develop work process procedures• Assess the ergonomics of each step of the process and implement improvements where needed• Perform Proof of Stations to determine accuracy of standard work and improve process flow of current products as well as developmental processes before release.• Manage and provide support in Risk Assessment activities.CAPAo Lead and/or provide manufacturing input for components or processes in questiono Analyzing properties of supplied components related to the issueo Reviewing and updating PFMEAs of processes in question• Plan and execute builds for process and product characterization studies for existing production continuity

Contract Quality Engineer(through Oxford Group) remote, part-time position(few hours per week)Tooling validations: test method, IQ, OQ, PQ, CQ documentation support- for plastic injection molding

•Implemented one piece flow to improve throughput time of deburring and in-process inspection processes Executed (scrap reduction) process improvements resulting in approximately $1000-$4000 monthly savings per part number.•Employed SMED in the Swiss machine areas, encompassing upstream processes as well as the mfg process. Annual savings approx $110k-$130k•Provided guidance for green belt and black belt projects of coworkers seeking Six Sigma certification•Provided plant-wide training in Lean Six Sigma•Worked with Cost Accounting to reduce labor and material variance issues

•Lead Six Sigma projects to implement new product manufacturing processes.•Facilitate QFD, FMEA, DOE planning and execution sessions for project teams that are not familiar with using DMAIC tools.•Utilized lean manufacturing methods such as Value Stream Mapping, Plan For Every Part in the planning of new manufacturing processes and facilities planning.•Managed the safety audits and ergonomic requirements for all machines in the pilot plant.•Provided training and assistance to personnel who take final ownership of the new manufacturing processes

•Lead kaizen teams to implement lean manufacturing and DMAIC processes. •Trained salaried and hourly employees in the use of lean tools, problem solving methods, and quality initiative tools.•Managed a department of 4 salaried and 1 hourly worker (who supervised 3 hourly people). Assigned projects, established responsibilities, managed departmental budget, gave yearly reviews, and professional development mentoring.•Worked closely with extrusion department to decrease scrap/ improve recovery.•Obtained Black Belt certification.

•Improved supplier processes to decrease rejects on incoming products. Overall effectiveness was a 28% decrease of rejected products.•Conducted problem analysis exercises on-site at the supplier to identify root cause and help implement corrective actions.•Led PPARs and organized PPAPs for John Deere factories in Iowa, Mexico, and Spain.•Worked extensively on process improvements with Aluminum casting suppliers and fuel systems suppliers both in the USA and abroad.•Trained new suppliers on how to create control plans and FMEAs.

•Special assignments included SPC implementation, leading ISO 9000 implementation, and developing SQA program.•Reduced lead-time on corrective action responses from 30 days to 14 days improving turn time for production returns.•Enhanced existing RGA/defect reporting system to yield more meaningful data.•Utilized Six Sigma techniques in gage R&R studies, and inspection methods on the assembly line.•Employed continuous improvement and root cause analysis techniques to improve quality and prevent recurrences of customer complaints.•Worked with suppliers to reduce process variations and inefficiencies by utilizing various lean and Six Sigma tools.•Developed Control Plans.

•Modified assembly stations to be more ergonomic and increased product throughput time.•Determined where inefficiencies existed and lead cross-functional teams to incorporate corrective actions.•Developed fixtures which improved welding throughput time by 10%.

• Resolved manufacturing problems by improving existing manufacturing processes• Specified and purchased assembly equipment for new products• Modified cell layouts to improve throughput time• Designed assembly cells for new products• Planned and implemented solutions to material flow, internal scheduling, and vendor delivery of parts• Designed fixtures and tooling for manufacture of new products• Prepared costings/quotes• Addressed and resolved customer complaints, implementing corrective and preventative actions• Developed and implemented prototype to production process to eliminate design and manufacturability issues before full production

Major Tier 1 and Tier 2 Automotive suppliers and Hydraulic valve manufacturer: braking systems, fuel systems, diesel engines, and HIC valves.(Cummins, Arvin, AlliedSignal, Danfoss): Managed every aspect of prototype builds. Performed process specification warrants for product manufactured in-house, lead FMEA teams, coordinated procedures for shipping prototypes to customers, participated as team coach for assembly team. Directed PPAP, 1PP and related builds. Actively participated on AQP team. Created quality standards , work instructions, and salvage procedures. Led process kaizen teams. Designed tooling and assembly fixtures utilizing CADKEY, Autocad, and Unigraphics. Redesigned components on tube mill and designed adjustable tooling fixtures for fabrication of car and truck mufflers. Implemented machining process improvements on cast aluminum and steel components. Planned and executed validation tests for prototype fuel injectors, and led problem solving teams.