Quality Engineer Lean Manufacturing

Juan Carlos Solis Castro

(US +1-510-***-**** / MEX +52-664-***-**-**) / email: ***********@*****.*** SUMMARY OF QUALIFICATIONS

• Manufacturing, Industrial and Quality Engineer with +25 years of experience applying principles of manufacturing leadership centered on World Class Manufacturing environments.

• Skilled liaison between headquarters and off-site manufacturing operations for NPI and transferring lines including but not limited to the implementation of procedures that comply with corporate guidelines.

• Experienced and trained in Six Sigma methodology as well as Lean Manufacturing tools and philosophies.

• Experienced in implementing, maintaining and auditing quality systems in ISO 9001:2015 / IATF 16949:2016

• Surveillance of CQI-23 Molding System Assessment Version 1:2014 and VDA 6.3 requirements fulfillment.

• Capable of quickly analyzing key cost drivers (e.g., Scrap, BOM’s, Balanced Score Cards, Product Costing, OEE metrics)

• Development and implementing a strategy planning to growth financial performance.

• Skilled in conducting team player roles and act as a change agent to reinforce team building synergy and empowerment.

• Bilingual English Spanish.

EDUCATION

Master’s in Business Administration (2011)

CETYS Universidad

B.S. in Industrial Engineering with emphasis in manufacturing (1993) Tijuana Institute of Technology

PROFESSIONAL DEVELOPMENT

• Six-Sigma Black Belt training completed by ASQ.

• Int’l Lean Manufacturing training completed by IIME.

• 5S principles and subsystems

• ASQ training courses completed as CQM Operational Excellence & CQE Certified Quality Engineer

• ASQ Member and participation for training Black Belts students

• APQP Core Tools Essentials trained / AIAG Diploma Certificate

• BSI / ISO-9001:2008 Lead Auditor Certificate.

• Partners in Leadership Accountability training course.

• Active participation in Health & Safety requirements and adherence to appropriate procedures including but not limited to IMDS guidelines.

• GMP’s and GDP’s

• Danaher Business System – Lean Manufacturing Certification CAREER ACHIEVEMENTS:

• Fully accountable for KS ISO-IATF 9001 Surveillance audit recertification.

• Black-Belt Coordinator of Lean-Six Sigma implementation in a project of $133K USD payback to Hunter Industries and fully accountable to implement Lean Manufacturing philosophies to foster a quality culture.

• Strategic participation to fully comply with Quality System ISO-9001:2008 certification, as well as TS-16949 Quality System Requirements for TOYOTA and NISSAN at Hunter Industries.

• 5S system companywide implementation at Hunter Industries.

• Fully accountable for surveillance on ISO-13485 [21 CFR 820] and FDA audits requirements.

• Management of IATF-16949:2016 and ISO 9001:2015 transitions.

• TQM implementation and Cellular Manufacturing System.

• Strategic participation to fully comply with APQP certification, as well as IATF-16949 Quality System Requirements for YANFENG and VALEO Customers at Plastikon Industries.

• Lead Cost reduction project of USD $150,000 savings at Shockwave Medical

• Information Technology Proficient: in Microsoft Windows (Word, Excel & Power Point)

• Software’s Knowledge as:, IQMS, AGILE, Minitab, MS Outlook & Teams, application software applied in the daily job duties.

• Lead CAPA resolution for improve and prevent nonconforming molded parts with a cost savings of 50k USD in Cepheid. PROFESSIONAL EXPERIENCE

KS Plastic Inc. – San Leandro, CA Jan 2023 to Current Plastics Injection Molding / Manufacturing (for Automotive industry). Quality Manager

• Lead KS QMS internal ISO/IATF audits.

• Ensure compliance of external audits in ISO-9001 / IATF-16949 requirements

• Manage the CAPA and Non-Conforming event system.

• Manage and oversee the Quality Department and personnel across the 3 shifts.

• Lead CARs for internal and external complaints resolution for improve and prevent nonconforming molded parts by using Quality and Lean Mfg., Tools.

• Develop core tools as PFD, PCP, PFMEA, SPC, GRR, Cpk for the automotive customers.

• Coordinate the implementation of validation testing with affected departments and training personnel.

• Analyze validation test data to determine whether systems or processes have meet customer validation criteria.

• Author to complete, compile, review and submit all PPAP documentation from Quality scope and submit for cross- functional customers approval (as part of APQP customer requirements).

• Participate in the “Management by Daily Improvements” meetings with stakeholders.

• Directly report to General Manager.

Cepheid Inc. – Lodi, CA Sep 2021 to Dec 2022

Plastics Injection Molding / Manufacturing (for Medical Device). Validation Engineer

• Lead CAPA resolution for improve and prevent nonconforming molded parts with a cost savings of 50k USD by using Danaher Business Systems and Quality Tools.

• Author of qualification test protocols (IQ/OQ/PQ) for addition of auxiliary equipment “relays” in manufacturing that result in an improvement cost saving of 35k USD.

• Develop validation master plans, engineering reports, process flow diagrams, work instructions or standard operating procedures.

• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.

• Execution of qualification/validation protocols working with various Lodi Site departments.

• Analyze validation test data to determine whether systems or processes have met validation criteria.

• Prepare detailed reports based on results of validation and qualification tests or reviews of procedures and protocols.

• Complete, compile, review and submit all protocol documentation and submit for cross-functional approval.

• Accomplish of qualification/validation projects by: o Ensuring compliance with corporate guidelines and FDA requirements o Networking with counterparts at other manufacturing sites to share best practices o Evaluating impact of procedural, equipment and process changes validation

• Estimate and schedule the time required to complete assignments and provide regular updates of progress

• Trained to Danaher Business System (DBS) and apply DBS tools as necessary.

• Directly report to Manufacturing Manager.

Topcon Positioning System Inc. – Livermore, CA Sep 2020 to Aug 2021 Manufacturer of Technology for Construction, Geospatial and Agriculture Markets. Sr. Manufacturing & Quality Engineer

• Manage and support the activities assigned of the Quality Inspection Master Data project development.

• Lead Topcon Livermore MRB management performance, monitoring and execute actions for improvements to mitigate or eliminate external and internal quality defects and non-conformances recurrences.

• Participate in the Strategy Deployment Action Plan: o Institute statistical process control for incoming material inspection and final inspection.

• Develop a process and tools for identifying incoming inspection based off prints and historical defects.

• Establish quality metrics that relate to the operation first pass yield.

• Update QAP-007 Control of Non-Conforming Procedure. The intention of these suggested changes is to have better control of MRB management practices from this process.

• Directly report to Quality Manager and dotted line to Director of Reliability and VP of Quality Shockwave Medical Inc. – Santa Clara, CA June 2019 to June 2020 Manufacturer of IVL Medical Products and Supplies.) Sr. Manufacturing & Quality Engineer

• Capacity model from each CER’s products assembly line.

• Line Balancing for each model running.

• Enhancement of current Manufacturing Process Instructions and creation from scratch some of them via DCO’s.

• Resolved all productions issues resolutions on swing shift (equipment downtime, QA rejects, equipment set-ups, etc.).

• NCR’s initiation and resolutions.

• IQ-OQ-PQ participation as well as Engineering Reports creation. Continuous Improvement initiatives:

• Implementing one-piece-flow system across the CER’s (Controlled Environment Room).

• Implementing Andon system across facilities (CER’s).

• Lead Cost reduction project of USD $150,000 savings.

• Lead cycle time improvement project of 25 % which impact directly to revenue.

• Strategic support for transferring product line to our contract manufacturing in Costa Rica.

• Directly report to Sr. Director of Manufacturing-Operations. Plastikon Industries. – Hayward, CA. USA. May 2017 to April 2019 Precision Injection Molding parts for Medical Device and Automotive Industries. BU Quality Engineer/Manager

• Principal Manufacturing and Quality Engineer at Plant III of Plastikon for our 1st parties Yanfeng and Valeo customers assembly lines which supply their products to our final customer TESLA automaker.

• Reduced the percent defective trends from 17.3 % to 3.54 % at Yanfeng assembly line in 6 months period.

• Supported various functions in Industrial engineering on the implementation of process/systems for 43 assembly operations and 12 Injections molding machines with capacity up to 1,900 tons to comply with IATF 16949:2016 / ISO 9001: 2015 and customer requirements.

• Produced scrap and defect trends charts as well as quality plans for improvements for corporate initiatives.

• Managed all the manufacturing and process activities, applying knowledge of plant layout, BOM’s, 5S philosophy, Lean tools and the production capabilities of all injection molding and assembly lines.

• Managed all quality activities from the different areas for incoming, in-process and finished goods inspections.

• Managed the customers complaints and 8D reports for continuous improvement efforts.

• Led, supported and validated new suppliers’ processes for our products and enhance existing suppliers.

• Coordinated molding validations for capability analysis (Cpk) measurements and GRR studies as part of PPAP process.

• Supervised training of indirect and direct personnel responsible for the support of assembly and molding operations.

• Generated and development of PFD, PFMEA, PCP and Inspections for CTQ with technology and techniques.

• Acted as Sustaining Quality Engineer for the APQP launch phases.

• Led studies to analyze, establish and improve labor requirements and standards associated with PCP inspections.

• Developed sampling procedures and instructions for recording, evaluating and reporting quality and reliable data.

• Wrote, revised and verified quality standards and procedures for inspections and measurements methods.

• Led MDI (Management by Daily Improvement) by coordinating Gemba walks for CI initiatives and Hoshin Kanri

• Directly report to Campus Quality Manager

Springs Window Fashions – Tijuana, BC. Mar 2015 to May 2017 Manufacturer of Blind, Shades and Drapery hardware. Principal Quality & Process Engineer

• Supervised, trained and developed 30 direct personnel and 2 Engineers responsible for the support and emphasis of the quality and process system functions.

• Ensured adherence to customer quality requirements and maintaining interdepartmental harmony, enhance 5S philosophy and with Kaizen events acting as a facilitator.

• Reduced 50% defects rate from 1.6% defective to 0.8% in 1-year period.

• Implemented Layered Process Audits (LPA’s) system for ensure process CTQ and CTP compliance.

• Developed, evaluated and improved manufacturing methods utilizing knowledge of industrial engineering norms and tools, parts fabrication processes, production equipment capabilities, assembly methods, manpower capabilities and quality standards as well as controlling scrap and defects rate at a plant level.

• Oversaw Quality and OEE metrics in order to ensure KPI’s performance are on target.

• Managed and implement quality and statistical tools (PFMEA, PCP’s, Cpk, 8 D’s and SPC) for problems solving, process measurements, process control and process improvement.

• Created and debugged work instructions; led and trained middle management and the operational employees to fully comply with customers CTQ’s.

• Managed activities with product and manufacturing engineering departments and corporate middle-management to validate process changes, new fixtures and Poka-Yoke devices.

• Led participation on corporate meetings as part of the Quality Steering Team within the company.

• Initiated Gemba-walks as part of the MDI strategic initiatives of Lean Manufacturing for CI efforts.

• Coordinated pre-launch production trial run process monitoring.

• Facilitated and promoted problem-solving techniques for effective root cause analysis and successful corrective action.

• Coordinate with Engineering, Production, and Tool room to resolve customer complaints via Poka-Yoke devices.

• Direct report to BU Manager.

Haemonetics Co. – Tijuana, BC. Oct 2013 to Dec 2014 Manufacturer of Blood Processing Technology.

Sr. Manufacturing Engineer (Temporary Contract)

• Oversaw the transferring of blood management products at the Tijuana Mexico site and assuring compliance of ISO13485 standard and FDA regulatory affairs fulfillment.

• Executed on-time of PQ’s protocol (as part of the IQ-OQ-PQ validations) including but not limited to the design, develop and implementation of U-shape line lay-out with continuous one-piece-flow system, bottleneck analysis and emphasis in MUDA’s elimination.

• Managed implementation of some of the 25 Lean tools such as Takt-Time, line balancing, Poka-Yoke fixtures for standard work and visual aids.

• Developed and deployed KPI’s for monitoring OEE, debugged MI’s procedures of product transfer, led and trained middle management and the operational employees to fully comply with customers CTQ’s.

• Coordinated activities with A.E. and Q.A. departments as well as corporate middle-management to validate the IQ’s / OQ’s / TMV’s protocols.

• Lea daily participation on Gemba meetings as part of Hoshin Kanri Policy Deployment program within the company.

• Developed and maintained product verification and testing documentation that was consistent with Quality System Regulations and compliant with both ISO 9001 and ISO 13485 standards.

• Direct report to Focus Factory Manager.

Hunter Industries – Tijuana B.C. Oct 2003 to Aug 2013 Plastic Injection Molding.

Sr. Quality & Process Engineer / Manager

• Implemented and coordinated a Black-Belt / Lean-Six Sigma project which resulted of $133K USD payback.

• Developed company strategy plan as part of my MBA diploma certificate.

• 5S companywide implementation and Policy Deployment strategy

• Implemented SPC, PFMEA, VSM, OEE, process mapping and statistics.

• Led and oversaw the process / mold qualification system (management by Automotive PPAP outlines) for new product lunches to meet customer requirements.

• Managed consistency from batch to batch, expanded SOPs toward ISO-9001:2008 structure.

• Provided technical expertise to create and maintain controlled and capable processes to ensure that all products are manufactured to meet customer fitness-for-use criteria at optimal manufacturing cost reflected at the products BOM’s.

• Formulated, negotiated and managed the annual Quality department objectives and budget, as well as the strategies and action plans to achieve those objectives.

• Directly responsible for developing, evaluating and improving manufacturing methods, utilizing knowledge of industrial engineering norms, product design, materials and parts fabrication processes, tooling and production equipment capabilities, assembly methods, manpower capabilities and quality standards as well as controlling scrap of the plant.

• Validated and authorized Standard Operating Procedures (SOP) of the Manufacturing and Quality activities

• Supervised, trained and developed 23 direct personnel responsible for the support and emphasis of the quality system on three shifts.

• Oversaw all process engineering including but not limited to new product introductions and transfer lines.

• Managed customer complaints, 8D’s corrective actions follow up and constant compliance.

• Developed and published ISO / TS procedures that support the quality system in place for automotive customers TOYOTA and NISSAN.

• Lead PPM’s improvement plan for strategic customers.

• Direct report to Operations Manager.

Platinadora Baja – Tijuana, BC Sep 2002 to Oct 2003 Metallic Plating Industry.

Quality Manager

• Reduced the defective trend from 5.0% and maintained on target of 2.0% avg. first pass yield.

• Developed standard procedures to implement and comply with I.S. EN ISO-9001: and 2000 Quality System model regulations and further certification plans.

• Led team-oriented problem solving by applying MSA tools.

• Approved and passed customer quality surveys in TS/QS-9000 and IS0-9001 Quality Systems.

• Extensively interacted with customers, suppliers and all levels of company personnel.

• ISO 9000 / QS 9000 system development. Developed, implemented and administered the Advance Product Quality Planning, Calibration systems and Supplier Development systems.

• Managed Calibration and Quality Assurance Technicians

• Direct report to Plant Director.

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