Site Quality Assurance And Regulatory Affairs Lead
Head of Quality Assurance and Regulatory Affairs for Medical and Industrial products
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@flextronics.com
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Luis Pavon is listed as Quality Assurance / Manufacturing Professional based in South Jordan, Utah, United States. AeroLeads shows a work email signal at flextronics.com and a matched LinkedIn profile for Luis Pavon.
Luis Pavon previously worked as Site Quality Assurance and Regulatory Affairs Lead at Foxconn Baja California and Sr. Director Quality at Flextronics. Luis Pavon holds Lean - Six Sigma from Villanova University.
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20+ year experienced professional in Manufacturing Operations and Quality Systems in the Medical Device Industry. Proven reputation to achieve improved Quality Systems and Regulatory Compliance, Implementation and application of Lean Manufacturing and Six Sigma methodologies resulting in improved Operational Performance.Specialties: Manufacturing Operations, ISO 9000 and ISO 13485, Quality Systems Regulations (21 CFR 820), Regulatory Submissions, Lean Manufacturing, Six Sigma, Design Controls,Project management.Key Contributions:Manufacturing: • Sponsored execution of over 10 major initiatives in technology transfer projects in a single year. For this, the site received Manufacturing Excellence Recognition Award.• Turned around a large manufacturing plant (1000+ associates and ~$50MM annual budget) with a history of under performance and critical quality issues. Within 2 years the plant received Manufacturing Excellence Recognition Award for the improvements made.Quality Assurance:• Led certification in ISO-13485 and CE mark.• Championed and sponsored Lean-Six Sigma projects generating over $5MM in yearly savings.• Led implementation of a “Product Use demonstration Program” intended to increase product quality awareness. • Chosen to lead successful remediation efforts in a site that had received an FDA Warning Letter.• As Management Representative, led sites in multiple FDA Inspections and ISO Audits eventually achieving ZERO Observations / Non-Conformances.
Listed skills include Manufacturing Operations, Quality Management, Leadership Development, Iso 13485, and 46 others.
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Tijuana, Baja California, Mexico
Head of Quality Assurance and Regulatory Affairs for Medical and Industrial products
Head of Quality for sustaining operations and Management representative
Greater Detroit Area
Dual role as head of Manufacturing Operations in Mexico and overall Quality Systems for the company
Greater Salt Lake City Area
Oversaw three manufacturing plants in Mexico and Brazil that involved the Molding, Assembly and Packaging of Intravenous Catheters, Hypodermal Syringes, Infusion sets and a Cannula Plant. Combined annual budget of $140MM and Capital expenses around $40MM. Managed three Plant Managers overseeing 1500 employees.
Juiz De Fora Area, Brazil
Led a manufacturing plant with 1000+ associates, ~US$50MM annual budget. My main goal was to turnaround an underperforming operation. My targets were to 1)Stabilize Plant, 2)Improve Plant Performance and Regulatory Compliance and 3)appoint my successor. All goals were successfully achieved, the plant received Manufacturing Excellence Award recognition.
Nogales, Mexico
1000+ Associates, $50MM in annual budget, over 350 SKU’s of finished products. PLant Achievements during this time:-Surpassed overall plant targets around financials and quality. No plant driven backorders. -Executed over 10 major initiatives around new products transfers.-Revamped CI, Lean and Six-Sigma programs.-Implemented Lean sampling plans for most.
Greater Salt Lake City Area
Oversaw 6 WW plants in Asia, Europe, Latin America and the US. Responsibilities included assurance plants had an effective Quality System in place and adhered to Unit Quality (Design Center). Approving and Managing activities related to New product development –from Concept to Launch as well as changes to Process or Product Design. Supporting sites during.
Nogales, Mexico
Responsible for en effective and efficient management of all Quality Systems related activities in the plant: Change Control, Auditing, Documentation, Customer Complaint handling, Internal Audit, Supplier Management, CAPA, Validation.
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Luis Pavon is listed as Quality Assurance / Manufacturing Professional.
AeroLeads has found 1 work email signal at @flextronics.com for Luis Pavon.
Luis Pavon is based in South Jordan, Utah, United States.
Luis Pavon has worked for Foxconn Baja California, Flextronics, Tangent Medical Technologies, and Bd.
You can use AeroLeads to view verified contact signals for Luis Pavon, including work email, phone, and LinkedIn data when available.
Luis Pavon holds Lean - Six Sigma from Villanova University.
Luis Pavon is listed with skills including Manufacturing Operations, Quality Management, Leadership Development, Iso 13485, Six Sigma, Fda, Quality System, and Iso 9000.
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