Marlene Guzman Monroy Email & Phone Number

Ewing, New Jersey, Us

ISO VV Facility Leader, Lead New Product Introduction for new formulations and packaging, MRB Champion, Facility Champion for Corporate Initiatives, Lead Audit representative. Lead on correction of formulation issues• Developed and coached 7 Quality Technicians and a Quality Engineer. Improving Testing Routines through process standardization and technical training set up and first level maintenance on Gas Chromatography and Refractometry.• Championed the reduction of MRB from $978K to $21K, in 2023-2024 through rework, earlier issue detection. Collaboration with Technical Teams for the PM procedures improvement.• Lead the project “Lab Test Redundancy & Reliability”. Reduced down time due Lab equipment issues, from 37 hrs in 2021 to Zero by 2024.• ISO 9001 Second tier Audit passed with 98 in 2022.• Successfully lead Victorville team to accomplish the implementation of 14 New. formulations for Liquid Laundry detergent and Cat litter plus 10 initiatives of new packaging.• CAPA process champion, responded 350+ Quality Events from 2020 to 2024. Provided 100+ hrs of training.

Shelton, Ct, Us

* SQF Chair - Leader for the Annual Certification at Inline plastics UT. Obtained excellent scores since 2016. Per NSF 100, 96, 98 & 98.* HACCP Chair - Leader of the Safety Food Assessments. Developed 20+ risk assessments including new machines and processes,* LSSBB certification - Developed and implemented LSS projects with a confirmed hard savings of $250K.* Lead Auditor for Internal and 2nd party Audits. Performed 30+ Audits at IPC and suppliers.* Developed, coach and managed 11 inspectors and a QE on a 24x7 high volume facility.* Working with corporate, supporting NPI of 100+ products at IPC. Provided statistical analysis to improve decision making.* Oversee daily operation. Provide guidance on daily activities related to GMPs, SQF and IPC quality standards, procedures, data acquisition and testing.* Customer complaints leader. Responded 50+ customer complaints following 8D and DMAIC methodologies. Reduced customer complaint on 40%.* Point of contact for the IPC UT major customer. Weekly visits to strength relations and resolve issues at customer facility. Developed IPC monthly score card to observe improvement. At 5.6 sigma level actually. * Supported Corporate initiatives for the IPC Quality System like the implementation of HQMs and Cpro. Developed 100+ inspection plans and oversee the daily documentation in the systems.* Lead Trainer. Provided 500+ hrs of training at all levels, related to quality topics and in support of the IPC quality systems.* MRB lead. Reduced the process time of a pallet in MRB by 80%.* Lead a six sigma projects for the improvement of the traditional leak test. Reduce the time of the test from 2 hrs to 20 mins average by using a pressure decay device.

Middleton, Wi, Us

* Championed Corporate PQP/PPAP (Part Qualification Process) Procedure. Training, proper implementation and use. Coordinator of procedure update and improvements. Managed and coordinate approval of +2000 PQPs* Corporate Quality Coordinator for transfer of a facilities. Managed the implementation of quality systems. The projects involved the qualification of forgings, die cast parts, stamping parts, pack out process, machining processes, lacquer and powder application and plating. Coordinate implementation of quality routines in-process, end of line and incoming. Create and implemented quality training programs for all personnel. Achieving in my last project 2013-2014 zero recalls and zero warehouse holds at project completion. * Assisted facilities in the creation of FMEAs and Control plans. Coordinated and executed design of experiments, process capability, R&R, appraisal gage design, SPC. 8D - Driven strong root cause analysis activities for meaningful corrective actions.* Supplier Quality Development. Arbitrage on quality issues between internal facilities and suppliers. Traveled from 25% to 100% to visit suppliers stayed up to 6 weeks at suppliers locations until completion of the issue.* Performed 10+ Quality Systems audits, acting as a Lead Auditor in 2 of them. Performed 50+ process and product audit as a result of new product introduction or customer complaints. * Corporate Quality Representative for finishing processes. Champion of Cosmetic Defect procedures and Standards.

Middleton, Wi, Us

QUALITY MANAGER 2000 - 2006Quality Manager -Make to Order Operation 2005-2006Quality Manager -High and medium volume Operation 2000-2005* Managed, mentored, trained quality engineers, lab technicians, quality leaders and inspectors. * Reduction of MRB inventory from $120K to $2K for the make to order facility and from $220K to $19K for the medium volume facility. Implemented systems, procedures and controls to keep inventory in low levels. * Implemented controls to reduction of DPMs. Achieving 600 to 500 DPMs in all facilities.* Championed Six sigma projects for the reduction of waste.

Quality Manager (1997-2000) - Implemented Quality Systems and procedures to obtain ISO9001 certification. Managed 10 auditors and 1 quality leader.Production Manager (1991-1997) - Managed 300 operators though 3 supervisors with a schedule of 100,000 lamps/week of 100 different models.Manufacturing Engineer (1990-1991) - developing training programs, visual aids, production standards/time studies, gage design, lay out design.