Pat Montello

About Pat Montello

Professional with over twenty years of experience with a high focus on operations and quality in engineering, consumer, and medical device industries. A proactive and results oriented leader with strengths in manufacturing, logistics, regulatory affairs, and quality systems. Held various roles where strong leadership qualities were further harvested and interest in the quality process increased to deliver mission-critical results. Specialties: Best practice experiences with lean manufacturing, quality improvement methods, systems integration, organizational development, and strategic planning. Would like to remain in the medical device industry focusing on quality throughout the process, from concept to product realization, with a desire for improvement and continued diligence that benefits both the end user and the company in the long run.Expertise:Data and Risk AnalysisISO 9001, ISO 13485, CFR820, MDSAP, EU-MDRMedical Device IndustrySystem validation and calibrationQuality Systems and AuditsProject and Personnel Management Licenses: FCC General Radio Telephone Operator: License # PG-GB-008717

Experience

1. Senior Quality Assurance Manager

   GAL Manufacturing

   Aug 2025 — Present · Bronx, NY, US

   Quality Planning & Strategy • Develop and implement quality strategies, SOPs, policies, and QC plans for new products. • Facilitate product Release to Manufacturing (RTM) processes. • Lead Continuous Process Improvement (CPI) initiatives across manufacturing.Quality Management System (QMS) • Establish, deploy, and maintain the company’s QMS in compliance with ISO standards. • Oversee internal audits aligned with departmental SOPs, work instructions, and forms. • Lead monthly Management Review Meetings and present Key Performance Indicators (KPIs).Audits, Compliance & Customer Interface • Plan, schedule, and host customer, registrar, and regulatory audits/visits. • Ensure compliance with ISO 9001 and other regulatory requirements. • Oversee Return Material Authorization (RMA) process. • Support design control and Engineering Change Notice (ECN) processes. • Conduct supplier evaluations and collaborate with supply chain on quality assurance.Metrics & Reporting • Monitor and report on quality metrics, including rejects, customer returns, yields, and performance trends. • Apply data-driven analysis to recommend improvements in manufacturing and quality processes.Leadership & Team Development • Recruit, train, and mentor quality department staff. • Provide coaching, guidance, and performance management to QA/QC team members. • Drive cross-functional collaboration to ensure quality excellence across projects.

Education

• Thomas Edison State University

  BS Applied Science and Technology, Electronic Engineering Technology (EET)

  1996 — 2001

• DeVry University

  AS, Electrical, Electronic Engineering Technology

  1983 — 1985

• edX Open Source - MIT

  Master of Science (MS), Business Administration and Management, General

  2015 — 2021

Skills

• 5s
• Continuous Improvement
• Manufacturing
• Calibration
• Electronics
• Process Improvement
• Metrology
• Iso
• Fda
• Analysis
• Quality Control
• Problem Solving
• Spc
• Lean Manufacturing
• Supplier Quality
• Quality Assurance
• Quality System
• Quality Systems
• Iso Standards
• Medical Devices
• Documentation
• Quality Auditing
• Team Building
• Quality Management