Guillermo López
San Juan
Summary
Industrial Engineer with experience in regulatory compliance, medical device and pharma manufacturing, facility management, supplier quality, inventory management, procurement, and quality engineering. Knowledge in quality tools & methods (i.e. risk assessment, root cause investigations, CAPA, change control and SOPs). Experienced in capital projects handling, packaging serialization (UDI and GS1), statistical analysis, process improvements, strategic sourcing, and business reviews. Experienced in 6σ tools to develop saving strategies, improve performance, efficiency, and profitability. Knowledge of FMEA’s potential effect and potential cause of failure. Skills in Minitab, CMMS Systems and Office 365 Suite (Word, Excel, Power Point, SharePoint, and Power BI).
Overview
17
17
years of professional experience
1
1
Certification
Work History
Quality Control & Customer Satisfaction Manager
Fuller Group
San Juan
12.2020 - Current
- Accountable for the Quality and Compliance program for Fuller Group
- Responsible for reviewing and implementing the Quality Policy, Manual and Program across all contracts
- Oversee the inspections and Customers Service Survey Program and run reports for Periodic Reviews
- Lead Fuller Group’s Supplier Quality Agreements companies and its clients
- Lead products and inventory qualification in customer’s sites for its intended use
- Regulatory (FDA) Point of contact for Integrated Facility Management, Janitorial & Housekeeping site programs
- Served as the Quality subject matter expert across all contracts to support investigation and events
Sr. Project Manager (Consultant)
MMM Holdings LLC
San Juan
08.2020 - 11.2020
- Developed project Work Plan for Multihealth Unit (MU, Government Healthcare Plan) in south of P.R
- Managed Work Plan activities (i.e., facility, marketing, resources, public relations, etc.) for the MU
- Worked closely with Multihealth Unit team to define transition process and Units operational metrics
- Completed analysis for medical specialties for the south region hospital with contracting and MMM team
- Managed and presented projects progress reports in Board of Directors forums including hospitals
- Managed Delegation Oversight process related to the transformation to a Clinical Risk Bearing Entity
Regulatory Affairs Sr. Specialist (Consultant)
Johnson & Johnson
Guaynabo
04.2018 - 08.2020
- Liaison between J&J One MD Medical Devices franchises and countries Health Authority Rep
- Tested and Kicked Off various projects with global/regional regulatory software MDRIM
- Performed change assessment for countries to build the standard production record (SPR)
- Evaluated and analyzed each country’s answer in their correspondent impact assessments
- Performed regulated product submissions following the International Medical Device Regulators Forum ToC
- Completed common technical documents and country specific for the standard production record’s fulfillment
- Fulfill and comply with the country’s Health Authority dossier submission package and specific documents
Senior Validation Engineer (Consultant)
Amgen
Juncos
11.2016 - 03.2018
- Completed Periodic Review and Periodic Monitoring activities related to Manufacturing Equipment Qualification/Validation
- Completed Non-Conformance (NCs) and CAPA documentation assessment as required per Amgen procedures
- Developed, analyzed, and presented results for operational and validation engineering projects
- Leaded complex assignments requiring development of new and improved validation engineering techniques and procedures for the Periodic Monitoring and Periodic Review Site Program
- Developed validation engineering policies and procedures for multiple organizational units
UDI Regulatory Project Manager (Consultant)
Stryker
Arroyo
01.2016 - 11.2016
- Managed the UDI (Serialization) Go-Live implementations for both Instruments and Endoscopy Business Units for Class II medical devices in Arroyo Site
- Managed UDI Capital & Expenses Budget, resource allocation, activities completion and deliverables planning
- Scheduled with both Instruments, Kalamazoo and Endoscopy, San Jose the pilot runs, label design, change control planning, implementation, and release dates for labels with UDI requirements
- Completed Component Supplier Change Process for Stryker vendors that resulted impacted as part of UDI
- Assessed and verified OEMs 510(k) premarket submission to schedule OEMs UDI new labels implementation
- Managed Sterility Assessments for Gamma finish goods with regulatory, sterility and packaging SMEs
- Managed Multilanguage project implementation for Instruments - Blood BU for Turkey market entrance
- Managed and scheduled with Cork, Ireland and Selzach, Switzerland UDI implementation for Endo p/ns
- Completed UDI budget submission for Direct Part Marking for 2017 activities
Sr. Engineer (Consultant)
Amgen
Juncos
09.2015 - 01.2016
- Complete Maintenance Job Plan creation and revision for Amgen's Full Potential Program (AFP), provide support for Reliability and Manufacturing System Owner's projects
Change Management (Consultant)
Zimmer Biomet
Ponce
08.2014 - 08.2015
- Participate in the ASL Remediation (Define Qualification Plan Requirements)
- Defined Change Control requirements for Supplier Acceptance Qualifications
- Lead Change Controls related to NCEs, Internal Quality Audits & CAPAs
- Implemented Supplier Qualification Change Management process for new and existing suppliers
- Completed Supplier information, sourcing requisition, define qualification plan requirements
- Reviewed and ensured that all Supplier information, documentation, and deliverables are provided
- Coordinate and lead weekly Change Control Review Boards, review change requests for accuracy
- Review change request to ensure applicable statutory & regulatory requirements are identified and incorporated
- Oversee and actively participate in the writing, creation, conservation, and control of quality system documents/records
Reliability & Quality Engineer (Consultant)
Johnson & Johnson
Las Piedras
02.2013 - 07.2014
- Conducted Suppliers certification (Contract Service Providers) for services and maintenance chemicals purchase
- Served as the War Room Coordinator and document reviewer before Quantic (FDA) team
- Completed Replacement Materials and Procurement SOP, work instructions and procurement transactions
- Completed new Training Curriculums for Maintenance Dept
- In Las Piedras, Lancaster and Fort Washington
- Ensure compliance in all 99 level SOPs, standards, forms and WI for LP, Lancaster, and Ft
- Washington sites
- Lead the evaluation for PFMEAs, criticality analysis for equipment and responsible for timely deliverables
- Completed SOPs, Training Plans, Trace Matrices, and process flows for LP, Lancaster, and Ft
- Washington site
Manufacturing Engineer (Consultant)
CR Bard
Humacao
08.2012 - 02.2013
- Completed Supplier/Component qualification for new monofilament for Ventrio/Davol
- Completed request information for Supplier for files update
- Completed (11) eleven BSi Packaging & Shelf-life validations for Davol Business unit
- Wrote and performed a PQP and PQR for new Branson Ultrasonic welding horn (for Davol Business Unit)
- Performed Risk Assessments Reports assuring that, with validation study, the equipment had the capability to manufacture units in compliance with specifications
- Completed MRRs & NCAP actions due to quantity discrepancy and unit misalignment
- Completed and released test EPOs for 16 (sixteen) new molds for 3D Max area for yield improvement
- Completed validation plan & EPOs for non-PFOA PTFE monofilament
Project Engineer
BD
Juncos
03.2012 - 07.2012
- Completed packaging validations for Alloyd Blister Machine (Epidural Mini- kits), lead productivity project meetings and support validations and project activities, provided support for mfg
- Activities and participated in the site validations
Technical Services Engineer
Pfizer
Barceloneta
11.2011 - 02.2012
- Participated in Pfizer Product Transfer Project, developed new and optimized procedures for new API controlled pharmaceutical areas, completed all the procedures for equipment, API modules, completed the procedure for the 103
- Building for the Pressurized Corridors Project for API, completed procedures for dispensing isolator for the OEV 4 & 5 API area
Quality Engineer
Medtronic
Juncos
05.2011 - 11.2011
- Create, route, and approve CR for the Endo Transfer Report (Surgical Technologies Business Unit), completed variability root cause analysis for lot holding issue, Business Impact Issue ($10k), completed product mix-up complaint for Jacksonville’s customer loyalty department
Process Engineer
GE
Humacao
07.2010 - 03.2011
- Completed new sample validation for the TQD trip unit project (Project estimation $600,000), implemented welding machines movement project efficiency impact of 15%, completed the QMS Project - Improved QMS data entry by 74% (From 24% to 98%), completed rivet machine purchasing project
- Downtime reduction (From 49% to 10%), resistance welding machines preventive maintenance owner
Process Excellence Coop
Johnson & Johnson
Las Piedras
01.2008 - 12.2008
- Participated in the Student Coop Program for the Process Excellence Department performing various projects in different manufacturing areas
Education
Certification - Hydraulics and Fluid Power Technology/ Technician
Motion Industries
01.2012
Master of Business Administration - Financial & Cost Accounting
University of Phoenix - Puerto Rico Campus
Puerto Rico01.2012
Bachelor of Science - Industrial Engineering
Polytechnic University of Puerto Rico
Puerto Rico01.2009
Skills
- Regulatory Affairs
- Supplier and regulatory audits
- Facility Management
- Project Management
- Equipment qualification
- Product Introductions
Certification
- Train the Trainer
- Lean Green Belt
Languages
- English, Full Professional
- Spanish, Full Professional
Timeline
Quality Control & Customer Satisfaction Manager
Fuller Group
12.2020 - Current
Sr. Project Manager (Consultant)
MMM Holdings LLC
08.2020 - 11.2020
Regulatory Affairs Sr. Specialist (Consultant)
Johnson & Johnson
04.2018 - 08.2020
Senior Validation Engineer (Consultant)
Amgen
11.2016 - 03.2018
UDI Regulatory Project Manager (Consultant)
Stryker
01.2016 - 11.2016
Sr. Engineer (Consultant)
Amgen
09.2015 - 01.2016
Change Management (Consultant)
Zimmer Biomet
08.2014 - 08.2015
Reliability & Quality Engineer (Consultant)
Johnson & Johnson
02.2013 - 07.2014
Manufacturing Engineer (Consultant)
CR Bard
08.2012 - 02.2013
Project Engineer
BD
03.2012 - 07.2012
Technical Services Engineer
Pfizer
11.2011 - 02.2012
Quality Engineer
Medtronic
05.2011 - 11.2011
Process Engineer
GE
07.2010 - 03.2011
Process Excellence Coop
Johnson & Johnson
01.2008 - 12.2008
Certification - Hydraulics and Fluid Power Technology/ Technician
Motion Industries
Master of Business Administration - Financial & Cost Accounting
University of Phoenix - Puerto Rico Campus
Bachelor of Science - Industrial Engineering
Polytechnic University of Puerto Rico
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