Aidelis Muñoz
Gurabo
Summary
Dynamic Quality System Manager with comprehensive expertise at Medtronic, focusing on regulatory compliance and project oversight.
Overview
22
22
years of professional experience
Work History
Quality System Manager
Medtronic
Juncos
01.2021 - Current
- People Leader sitewide and Process Owner of QMS operations including Change Control, Engineering Changes, FW/SAP Configuration Management, Training Specialist (LMS), and DHR Complaints group.
- Primary QMS Process Expert at Juncos Site.
- Inspection Audit Compliance Leader.
- Support New Product Introduction Engineering team product lifecycle process perusing organization goals with sustaining and project teams.
- Collaborate with process improvement projects for the operational and manufacturing area for product quality and enhance customer and patient business needs resulting in process optimization and harmonization.
- Assist Organizational Stakeholders’ and teams for manufacturing operations strategies and goals.
- Collaborate and support external departments (areas), such as: Quality, Manufacturing, Engineering and other stakeholders to be aligned with the process established.
- Develop and monitor KPIs as part of organizational excellence performance metrics.
- Project Management of Quality System Projects (Simplification, Standardization and Harmonization).
Principal Compliance/Audit Specialist
Medtronic
01.2019 - 01.2021
- Owned audit readiness and execution for internal/external inspections, including FDA and ISO.
- Reviewed and approved risk assessments and regulatory submissions.
- Led site and sister facility audit programs, including remote backroom operations.
- Managed Quality Review and Management Review activities with executive leadership.
Principal Quality System Specialist
Medtronic
01.2012 - 01.2019
- Directed QMS project strategy, change control governance, and global training metrics.
- People Leader of Document Control, Configuration Management, Training Specialist and Record Retention personnel.
- Served as SME for Training & Change Control in audits across multiple facilities.
- Supported organizational strategies and goals with technologies and support product transfers and new product introduction training requirements, risk management and change control processes.
Principal Training and Development Specialist
Medtronic
01.2011 - 01.2012
- Assured internal compliance with regulation requirements and changes regarding Training Compliance & Document Control.
- Supervise Training Group, owner of training materials, New Hire program and Documentation Control personnel.
- Support Audit/Compliance Inspections (Front Room and Back Room roles).
- Develop technical training curriculum and requirements to ensure they are adequate and up-to-date with process and technology changes.
- Maintained and updated the Training Area technologies to assure instructions are up-to-date with process and technology changes; and the plant GMP Computer-based Training program for all employees.
Senior Training & Document Control Supervisor/Training Supervisor
St. Jude Medical, PRLLC
Caguas
01.2006 - 01.2011
- Assured internal compliance with regulation requirements and changes regarding Training Compliance & Document Control.
- Supervise Training Group, owner of training materials, New Hire program and Documentation Control personnel.
- Coordinate and support Audit/Compliance Inspections (Front Room and Back Room roles).
- Prepared and recommended budgets for the Training and Documentation Departments.
- Supported Start Up Activities for Arecibo new location during 2006-2010.
Documentation Specialist
St. Jude Medical, PRLLC
01.2006 - 12.2006
- Served as liaison between facilities regarding and process approved document change orders.
- Implemented systems for the secure storage of all quality records.
- Maintained centralized reference file of all controlled documentation and system to provide control for obsolete documentation.
- Distributed new releases or revised documentation in accordance with established procedures, translate and publish manufacturing procedures.
- Supported with Document Control Productivity & Trends Metrics.
Executive Assistant
St. Jude Medical, PRLLC
01.2004 - 01.2006
Education
MBA - Human Resources Management Administration
Ana G. Mendez
Caguas, PRBA - Business Administration
University of Puerto Rico
Humacao, PRSkills
- Project management
- Regulatory compliance (FDA, ISO 13485)
- Audit inspections
- Change control and document governance
- Training and learning management
- Lean and Six Sigma (Green Belt)
- Process optimization
- People leadership and talent development
- Risk management
- Data-driven decision making
- Change control process ownership (Agile/MAP)
- Configuration management (MES)
- Quality management systems governance
- Patient-first program
Certifications Training
- ISO 13485 Lead Auditor
- CMMI Certification – Case for Quality (VIP Appraisal Program)
- Lean Six Sigma (Green Belt)
- People Leadership Training Academy
- CAPA System Expert/Owner/Board Member Approver
- Project Management
- System Applications Experience (ERP Systems such as: Microsoft, SAP, CSOD, MES, PLM Agile/MAP, Windchill, SumTotal, Power BI Metrics, Complaint Handling Systems, Smart Solve for Complaints.)
- Regulatory & Compliance: ISO Regulation and Medical Devices Regulations (QMS SME)
- Process Owner SME (Quality Management System Governance)
Achievements Organizations
- Medtronic Symbolic Employee (Puerto Rico Manufacturers Association) - 2023
- Women Network, GERG PR
- Organizational Health Survey (Solid Results over 98%)
Timeline
Quality System Manager
Medtronic
01.2021 - Current
Principal Compliance/Audit Specialist
Medtronic
01.2019 - 01.2021
Principal Quality System Specialist
Medtronic
01.2012 - 01.2019
Principal Training and Development Specialist
Medtronic
01.2011 - 01.2012
Senior Training & Document Control Supervisor/Training Supervisor
St. Jude Medical, PRLLC
01.2006 - 01.2011
Documentation Specialist
St. Jude Medical, PRLLC
01.2006 - 12.2006
Executive Assistant
St. Jude Medical, PRLLC
01.2004 - 01.2006
MBA - Human Resources Management Administration
Ana G. Mendez
BA - Business Administration
University of Puerto Rico