Magdalena Galvan Campos
Tijuana, Baja California,BCN
Summary
Good Communication skills to optimize relationship and team work Dynamic and Multitask capability Organizational and Planning skills. Enjoy learning of new stuff and new challenges. Ability to lead staff.
Overview
18
18
years of professional experience
Work History
Sr Quality Complaint Analyst
Outset Medical
12.2021 - 11.2024
- Generate complaints in a daily basis from cases reported from Field to Technical Service.
- Complete complaint file according to the problem solution that was performed by the Field Service Engineer (FSE).
- Performed data analysis, provide trends to R&D team in order to identify emerging issues to be attended and escalated to investigations or CAPAs.
- Monitor and implement activities to decrease complaint backlog and improve Complaint metrics as aging and Cycle time.
- Performed Trending data for Management Review.
- Performed weekly reports to Manufacturing operations.
- Assisted in the development and release of comprehensive training materials, for complaint process. and Trending complaint process, ensuring consistency and quality across the team.
- Complete MDR process for reportable complaints.
- Collaborate to perform the PMS report, gathering and analyzing the data from 2 years.
Quality Engineer
Integer Holdings Corporation
05.2015 - 07.2020
- Follow up Non-conforming Reports from process
- MRB control, report product in HOLD, and follow up to decrease quantity on MRB
- Decrease of CAPA’s Opened, complete overdue tasks and maintain current CAPA’s metrics on Time.
- Provide support to manufacturing lines and defects from process.
- Update Risk Management documents (Process Control Plan, FMEA, Risk Management).
- Perform Engineering Studies and report findings.
- Review and approve protocol and report qualifications, engineering studies, NPI Protocols and Reports.
- Perform change records with the appropriate reason for change and justification to Update Quality Inspection, Manufacturing Procedures to improve images, clarify acceptance criteria, clarify process steps.
- Monitoring of Quality Metrics assigned based on Quality Goals.
- Part of Internal Auditor group as Lead Auditor
- Perform Internal Audits (Control Process, Warehouse, Acceptance Activities, etc) coordinate the auditor team, coordinate opening and closure meetings, and perform audit report.
- Transfer subassembly process lines from sister companies to local manufacturing process as part of cost reduction projects.
- Release components and subassemblies, including their respective inspection procedures.
Quality Engineer
Medplast
12.2014 - 05.2015
- Investigation and proposal of corrective actions for customer complaints backlog.
- Follow up daily with customers Supplier Quality Engineers.
- Complete Backlog of Report Qualifications of Molding process Validations.
- MRB control, report product in HOLD, and follow up to decrease quantity on MRB.
- Answer and follow up findings from Customer Audits.
- Supervise QC Inspectors to complete samplings to molding process qualifications.
- Provide support to manufacturing lines and defects from process.
- Update several procedures to align with current practices.
Quality Engineer III
Tyco TE Connectivity
08.2014 - 10.2014
- Monitoring and report CPM
- Complaints investigation thru TECHS System, customer system and mail.
- Provide and collect data for FAI for finished product.
- MRB control, report product in HOLD, and follow up to decrease quantity on MRB.
- Create Remediation Plan to improve Quality System (Quality Control and Quality Assurance)
- Supervise QC Inspectors.
- Provide support to manufacturing lines and defects from process.
Quality Engineering Supervisor
MEDTRONIC Mexico
12.2009 - 07.2014
- Monitoring and report DPM, RTY Indicators for Catheter products.
- Trend Reports and Monitoring for process indicators: DPM’s, Non Conforming Report, Non Conforming Report days to disposition, Process Audits, CPM’s
- Follow up to SPC tool.
- Create new collection plans at WinSPC for new products.
- Control and manage of quality issues originated at production lines.
- Collaborate to perform the PMS report, gathering and analyzing the data from 2 years.
- 8 D’s, Fish Bone, Cause and Effect Matrix, SIPOC.
- Create Change Orders using Agile System.
- Team work to implement Corrective actions on Date
- Control of Non Conforming Product as define root cause, containment actions, corrective actions, disposition and scope.
- Determine the material disposition through statistical analysis.
- Develop Engineering Investigations for material disposition.
- Participate in product transfer.
- Lead Quality Engineers Group of 4 Engineers
- Lead QC Inspectors group of 19 QC inspectors
- Manage and control of Raw Material in Hold status
- Develop of Engineering Reports
- Review and approve Qualifications of equipment and process
- Participate on Certification Program to train Engineers on follow up NCMR’s.
- Complete project “Release Time Reduction for POBA Products” (LSPR00044875) reducing lead time and also with a cost saving of $106, 592.
- Complete project “Tip Sand Reduction” (LSPR00057935) reducing the Sand Disc use on 50%, with a cost saving of $46, 476.
- Participate on new product NC Euphora transfer with the following activities: Lead and coordinate training for all work stations (15 work stations).
- Implement Certification program for operators. (Procedure change, minimal training requirements needs form, training evaluation document, training program document)
- Implement Process Test Methods to evaluate NC Euphora product (Burst test, tensile test Qualifications).
- Qualify NC Euphora Pyrogen test method, Translation of Visual Aids and support to manufacturing process during debug runs.
- Update ASL with new suppliers for Medtronic Mexico (Direct contact with suppliers)
- Release in SAP system new components that will be purchased directly from Medtronic Mexico.
- Implement and train Receiving Incoming inspections in the Inspections Plans for new components, Direct contact with Senior Quality Engineer and Packaging Support Engineering Supervisor to implement NC Euphora new components. (Daily meetings, coordinate visit to Medtronic Mexico, daily status reports and calls)
Quality and Release Supervisor
COVIDIEN Nellcor Puritan Bennet
03.2008 - 11.2009
- Monitor and Control Product Non conforming
- Supervise 15 inspectors from 10 main production areas and Release Department.
- Manage quality issues originated at production cost centers.
- Supervise Release Department; assure accomplishment of the Quality documentation requirements.
- Close work with Production and Engineering departments to attend daily priorities.
- Generate reports to corporative visits and trend presentations.
Complaint Engineer
COVIDIEN Nellcor Puritan Bennet
08.2007 - 03.2008
- Receive, follow up, investigate root cause and propose corrective actions to customer complaints.
- Notify Engineering support regarding new complaints, alert operators from work areas regarding the customer complaints.
- Close work with Product Monitoring according to customer complaints flow.
- Samples complaints monitoring and evaluation.
Engineer assistant
COVIDIEN Nellcor Puritan Bennet
02.2007 - 08.2007
- Professional Practices given support for engineering activities.
- Receive, follow up and answer customer complaints.
- Non conforming Audits findings answer.
- Support to generate line balances.
Education
Green Belt Certification -
Medtronic Mexico
Tijuana, Baja California, Mexico04.2013
Green Belt Lean Six Sigma Training -
IDET
Tijuana, Baja California, Mexico12.2012
Training and Certification - Lead Auditor ISO 13485:2003
BSI
Tijuana, Baja California, Mexico05.2010
Degree - Chemistry Engineer
Universidad Autónoma de Baja California
01.2006
Quality System Internal Audit Course - ISO 19011:2002
10.2007
Skills
- Problem-solving
- Time management
- Multitasking Abilities
- Team collaboration
- Decision-making
- Work prioritization
Professional Focus
- Good Communication skills to optimize relationship and team work
- Dynamic and Multitask capability
- Organizational and Planning skills
- Enjoy learning of new stuff and new challenges
- Ability to lead staff.
Languages
English
Advanced (C1)
Timeline
Sr Quality Complaint Analyst
Outset Medical
12.2021 - 11.2024
Quality Engineer
Integer Holdings Corporation
05.2015 - 07.2020
Quality Engineer
Medplast
12.2014 - 05.2015
Quality Engineer III
Tyco TE Connectivity
08.2014 - 10.2014
Quality Engineering Supervisor
MEDTRONIC Mexico
12.2009 - 07.2014
Quality and Release Supervisor
COVIDIEN Nellcor Puritan Bennet
03.2008 - 11.2009
Complaint Engineer
COVIDIEN Nellcor Puritan Bennet
08.2007 - 03.2008
Engineer assistant
COVIDIEN Nellcor Puritan Bennet
02.2007 - 08.2007
Degree - Chemistry Engineer
Universidad Autónoma de Baja California
Quality System Internal Audit Course - ISO 19011:2002
Green Belt Certification -
Medtronic Mexico
Green Belt Lean Six Sigma Training -
IDET
Training and Certification - Lead Auditor ISO 13485:2003
BSI
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