ROBERTO L. MUNOZ

** *********** ***** 787-***-****

Cheshire, CT 06410 Email: ac6m8s@r.postjobfree.com

PROFILE

Highly skilled and accomplished Plant Quality Director, Engineering Manager and Director of Manufacturing Quality with demonstrated skills in the implementation of ISO 9000, ISO 13485, SPC, manufacturing process controls, cost efficiencies, productivity improvements, and bottom-line profitability.

COMPETENCIES

Strategic Planning

Goal Setting/KPIs

Lean Manufacturing

Self-Directed Work Teams

Process Improvements

Cross-Functional Team Facilitation

Quality Standards

Change/Transformation Management

Six Sigma Methodologies

Continuous Quality Improvement

WORK EXPERIENCE

MEDTRONIC, North Haven, CT 2010 – Present

PLANT QUALITY DIRECTOR, Covidien Plant

Lead a team of 4 Quality Managers, 5 Principal Quality Engineers, 23 Quality Engineers and 146 quality support personnel and technicians to partner with manufacturing functions at a plant consisting of ~1,200 full-time employees and ~500 temporary workers.

Establish and implement quality standards and Best Practices relying upon documentation, analysis, education and communication.

Collaborate cross-functionally with internal departments to build consensus and support for shared goals and quality processes.

Establish quality goals and Key Performance Indicators (KPIs), followed by real-time data collection, analysis and trending.

Use analytics to take a proactive versus reactive response to risks and opportunities.

oProcess FMEA as a living document to prioritize reduction of high risk items

oCross factory quality alert review

Serve as a change agent, working with internal customers to continuously improve quality systems.

Built a culture of quality allowing it to become part of the plant-wide philosophy.

oDeveloped a product demonstration course for new hire employees to build awareness around the products we make and the importance of producing quality products, with an emphasis on patient outcomes.

oEstablished recognition standards to recognize employees for demonstrating quality behaviors

oFacilitate yearly "Quality Days” to promote quality improvements and activities campus-wide

oImplemented processes to engage manufacturing employees with communicating quality concerns and improvement ideas

Accomplishments

Won Manufacturing Quality Best Plant Award (2016) selected among the 88 Medtronic Plants worldwide.

Achieved 75% reduction on manufacturing and supplier-related product holds.

Achieved zero non-conformances in last eight notified body audits.

Implemented a Supplier Quality Begins With Me Program with product awareness.

Implemented state-of-the-art processes including SPC, MPC, Six Sigma, GMP, ISO 9001 and 13485: 2016, and FMEA.

AST FF QUALITY MANAGER

Managed a staff of 2 Principal Quality Engineers, 6 Quality Engineers and 36 quality support personnel and Technicians.

Changed the paradigm of quality from a cost center to a value-added group, linking quality to cost avoidance, risk mitigation and product reliability/integrity.

Led transformation management initiatives with a focus on continuous quality improvement.

oDriving of “surgeon table” problem solving analysis process

oCross functional team understanding and involvement in quality review and issue resolution

Partnered with the AST Manufacturing Manager to develop quality awareness activities and education on the production floor

Collaborated daily with various manufacturing functions to ensure adherence to quality systems

ROBERTO L. MUNOZ Page 2

Resumé (Continued)

PLANT QUALITY MANAGER, Ponce, PR

Managed a team of 4 Quality Managers, 6 Quality Engineers and 63 quality support personnel and Technicians.

Reviewed and managed quality systems including complaints, CAPA, document control, change management, incoming inspections, validations, and environmental controls.

Used real-time analytics as a baseline for continuous quality improvement.

oImprovement project development based on quality metrics

oCAPA process to drive process enhancement and horizontal deployment to additional areas

Managed self-directed teams with a focus on process improvement and lean staffing.

Accomplishments

Developed label reconciliation process to reduce divisional product holds by 50% in one year.

Created Ship-to-Stock process, which was deployed across the business unit.

QUALITY SECTION MANAGER

Managed a team of 3 Engineers, 1 Supervisor and 12 Quality Control Technicians for ENDO access focused factory.

Introduced methodologies including root cause analysis and use of analytics to implement permanent solutions.

Accomplishments

Developed and implemented line clearing processes to reduce non-conforming reports by 85%.

Reduced labeling related complaints by 50%.

WORK EXPERIENCE (Continued)

HAMILTON SUNDSTRAND, Santa Isabel, PR 2007 – 2010

ENGINEERING MANAGER

Managed a team of 36 Engineers and 20 Technicians with an operating budget of $3 million.

Developed and implemented strategies and processes for productivity improvement, calibration, preventative maintenance, new product development, engineering change requests, and routing/JIS development.

oEstablishment of the Manufacturing Engineering/Quality Assurance Cell

oUse of A3 analysis to drive improvement

CARDINAL HEALTH, LLC, Las Piedras, PR 2004 – 2007

DIRECTOR OF MANUFACTURING QUALITY

Developed quality systems to ensure compliance with ISO 9000, FDA and HIPAA from a start-up operation.

Tracked team on Six Sigma and Lean Manufacturing.

Led a team of 3 Quality Engineers and 7 Quality Technicians

Accomplishments

Developed and deployed quality system in compliance with ISO 9000, eGMP and HIPAA.

Developed and implemented quality data collection system and analysis that drove process sigma from 3.9 to 5.1 Sigma.

Directed project management on shipping cost reduction, which resulted in $1.2 million annual savings.

Implemented skip lot incoming inspection process

MANUFACTURING TECHNOLOGY SERVICES, Caguas, PR 2003 – 2004

DIRECTOR OF ENGINEERING

Responsible for the complete engineering operations.

Led a team of 3 managers, 12 manufacturing engineers and 17 engineering and maintenance technicians

Developed data collection system to track and monitor quality data and drive corrective actions for continuous process and quality improvement. Achieving a 35 % defect reduction and driving a 25 % productivity improvement.

Introduced process development for compliance with GMPs and FDA regulations for the new product introduction for medical devices.

Responsible for the overall plant/facilities maintenance and the new products introduction process.

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Resumé (Continued)

GENERAL ELECTRIC, Patillas, PR 2002 – 2003

PROJECT MANAGER, Black Belt

Served as a project manager for factory’s cost reduction and productivity improvement programs, including performance assessment and financial results analysis.

Functioned as new product introduction process owner responsible for coordinating all introduction activities with cross-functional teams.

Led management activities for cost reduction projects, achieving $2.07 million in savings for 2002.

Responsible for the NPI quality metrics and coordinated with cross-functional team to reduce new product delinquency by 85%.

INTEL, Las Piedras, PR 2000 – 2002

GLOBAL PROJECT MANAGER

Management of the team responsible for the design and deployment of wireless paging and cell phone systems to enable communication for Intel employees in the America’s region.

Managed and coached 18 corporate Switchboard Operators in five virtual sites across the United States.

Negotiated deal with subcontractor to achieve a $120K annual savings.

Drove wireless site coverage improvement from 20% to 75% in one year.

EDUCATION

UNIVERSIDAD DEL TURABO, Caguas, PR

Master of Business Administration in MANAGEMENT, December 2010

MARQUETTE UNIVERSITY, Milwaukee, WI

Bachelor of Science in ELECTRICAL ENGINEERING & COMPUTER SCIENCE

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