Evelyn Montes
Guayama
Summary
Professional with vast experience in the pharmaceutical, medical devices and electronics manufacturing environments with expertise in operational excellence, process improvement root cause analysis, auditing, validations and product and process transfers, quality systems, Regulatory compliance of FDA cGMPs, CFR820, CFR part11, ISO9000, ISO13485 and ISO14000, Lean Manufacturing methodology, VSM Six Sigma certified, and CQE,CSQE trained with experience supervising up to30 direct reports. Visionary, versatile, team and goal oriented resource with skills: MS Access, Visual Basic, MS Word, MS Excel, MS Power Point, Minitab, MS Project, Compliant Pro, SAP & BPICS ERP systems, Bilingual English & Spanish.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Compliance Specialist/Consultant
Kelly SETT, Juncos PR
Juncos, PR
06.2023 - Current
- Support the Investigations, Complaints and CAPAs structure to provide guidance and leads efforts to improve compliance processes and reduce events/deviations in the operations department
- Provides technical support for the investigation of product/process deviations and CAPA determination to ensure are maintained in compliance and according to established Company and Corporate standard operating procedures, policies, regulations, and current GMP guidelines
- Accomplishments:
- Completed investigation and correction process involving omission of process, and documentation, facility environmental controls change management, Business process capacity and constraint resolution for investigation department
Sr. Configuration Assurance Supervisor
Medtronic, Juncos PR
Juncos, PR
09.2017 - 04.2023
- Responsible for Configuration Management/Document Control Dept
- Oversees change control Process of quality procedures, work instructions, quality records, tool specifications, test plans, manufacturing execution system and business system configurations (SAP)
- Custodes and monitor engineering change process and change control review boards
- Accomplishments:
- Completed implementation of MCT configuration Tool to remove compliance issues
- Expanded operation to2nd shift improve customer service
- Lead implementation MAP WAVE3
- Lead critical CAPA investigations with Engineering Change Order program
- Restructured the Document Retention Area to achieve controlled environment
Validation /Compliance Engineering Consultant
Contractor, Nypro PR, Cayey PR Mentor Technical Group
Cayey, PR
08.2017 - 09.2017
- Support engineering team with mold validation and capacity evaluation
- Accomplishments:
- Assigned to MITG Flex project, focused on increasing flexibility within the manufacturing operation
- Outlined documentation framework: change control, SCR, PPAP checklist, test request
Validation /Compliance Engineering Consultant
Contractor, Bristol Myers Squib, Humacao PR Mentor Technical Group
Humacao, PR
07.2017 - 08.2017
- Write and execute computer qualification and validation documents
- Accomplishments:
- Complete validation reports for software and facilities validation processes
Project Coordinator
Contractor, UTC, Santa Isabel PR Mentor Technical Group
Santa Isabel, PR
06.2016 - 07.2017
- Project Coordinator functions: apply lean manufacturing tools to improve materials management processes focused on inventory reduction
- Lead supplier integration efforts for lean cell transformation processes focused on level loading scheduling processes
- Accomplishments:
- Achieve Materials Managements Process Maturity improvement from1.7 to3.6
- Potential savings of project5M materialize1.9 M
Quality specialist
Contractor, Customed, Fajardo PR
Fajardo, PR
09.2015 - 03.2016
- Quality specialist functions: Worked CAPA , Customer Complaints, Engineering Change Management
- Quality Systems Remedial work
- Accomplishments:
- Lead change management project to bring over200 engineering change orders to closure
OpEx | QA Leader
Eaton Electrical Corporation, Coamo PR
Coamo, PR
01.2010 - 01.2015
- Administered QA compliance and corrective and preventive action programs
- Supervised supplier quality laboratory, calibrations and configuration document control areas
- Perform audits supporting ISO14000 readiness
- Worked with registrars such as UL, CQC, CSC and DNV
- Accomplishments:
- Implemented In process Quality surveillance, in assembly operations
- Achieved an increment of productivity29% in incoming lab
- Integrated Customer Quality Management CAPA software program, Change Management review process and Annual quality campaigns
- Lead qualification activities (PPAP) for improvement and product transfer projects for Molding and Stamping processes
- Hosted7 process assessment maintaining ISO Certification Status for the facility
- Pursued and achieved the American Bureau of Shipping (ABS) certification which, enabled marketing for offshore applications in the orient
QA Supplier Manager | QA Operation Section Lead | Operational Excellence Manager
Covidien, Ponce, PR
Ponce, PR
01.2005 - 01.2010
- Oversaw incoming supply quality, managed Dock to Stock supplier program, and supervised Supplier Quality Engineering Staff
- Lead business unit QA activities supporting timely product release, non-conformance management, regulatory compliance
- Managed the site level process improvement resources for Mentor Technical Group team
- Accomplishments:
- Designed and implemented out of specification procedures, reduced testing bottle neck by92%
- Lead Quality Operation for Access and Ports Operation, Supervised Quality Technicians, Review and approve CAPA and Product Non-Conformance Investigations
- Implemented final document review improvement project to reduce product release cycle times by reducing documentation traveling processes
- Achieved $3.5
- Million in savings Certified3 six sigma black belts and4 green belts Instituted the Project Management process Developed Six Sigma Blue Belt training course
Validations Manager | Mfg. Work Center Manager | Mfg. Work Center Supervisor
Mcneil Consumer Healthcare, Las Piedras, PR
Las Piedras, PR
01.1998 - 01.2005
- Coordinated and supervised activities related qualification and validation work for process improvement and technology transfer processes
- Provided support and technical assistance to production work units
- Lead Operation of tablet Coating and Printing departments Supported the operations metrics in productivity, quality, cost and safety
- Accomplishments:
- Lead validation activities for new product introduction processes and achieved FDA pre and post approval processes for new technology and product transfer process
- Participated and Pre-Approval FDA audit processes presenting validation processes
- Improved batch record quality metrics by reducing execution errors and increasing end product availability
- Achieved general cycle time reduction and $800 K in inventory reduction
- Used for Six sigma BB certification
- Created compliance shop floor structure and process improvement program within manufacturing, improved compliance commitments across six manufacturing areas and established a productivity management program
Computer Validations Specialist
Baxter Healthcare, Aibonito, PR
Aibonito, PR
- Led standard operating procedure annual review processes, complex non-conformance investigations and root cause analysis of non-conforming events
- 5 years
Education
Master degree - Business Administration, MBA
University of Phoenix
Arizona, USBS - Computer Science
Interamerican University
San German Campus, PRCertification
- Johnson & Johnson Certified Six Sigma Black Belt
- ASQ CQE, CSQE academia trained
- Baxter Healthcare Six Sigma Engineer
Languages
Spanish
Proficient
C2
English
Proficient
C2
Timeline
Compliance Specialist/Consultant
Kelly SETT, Juncos PR
06.2023 - Current
Sr. Configuration Assurance Supervisor
Medtronic, Juncos PR
09.2017 - 04.2023
Validation /Compliance Engineering Consultant
Contractor, Nypro PR, Cayey PR Mentor Technical Group
08.2017 - 09.2017
Validation /Compliance Engineering Consultant
Contractor, Bristol Myers Squib, Humacao PR Mentor Technical Group
07.2017 - 08.2017
Project Coordinator
Contractor, UTC, Santa Isabel PR Mentor Technical Group
06.2016 - 07.2017
Quality specialist
Contractor, Customed, Fajardo PR
09.2015 - 03.2016
OpEx | QA Leader
Eaton Electrical Corporation, Coamo PR
01.2010 - 01.2015
QA Supplier Manager | QA Operation Section Lead | Operational Excellence Manager
Covidien, Ponce, PR
01.2005 - 01.2010
Validations Manager | Mfg. Work Center Manager | Mfg. Work Center Supervisor
Mcneil Consumer Healthcare, Las Piedras, PR
01.1998 - 01.2005
Computer Validations Specialist
Baxter Healthcare, Aibonito, PR
- Johnson & Johnson Certified Six Sigma Black Belt
- ASQ CQE, CSQE academia trained
- Baxter Healthcare Six Sigma Engineer
Master degree - Business Administration, MBA
University of Phoenix
BS - Computer Science
Interamerican University