Joe Fuertes
Oceanside
Summary
Dynamic Sr. Complaint Investigator with extensive experience at Philips/Respironics Inc., excelling in complaint investigation and MDR reporting. Proven track record in regulatory compliance and data analysis, driving timely resolutions and enhancing customer relationships. Adept at trending analysis and audit participation, ensuring quality assurance in critical care devices.
Overview
39
39
years of professional experience
Work History
Sr. Complaint Investigator
Philips/Respironics Inc.
Carlsbad
08.2003 - 10.2025
- Investigate and confirm customer reported complaints and prepare a record of investigation including causes of failure and conclusion.
- Drives closure of product complaint notification and other notification in a timely manner.
- Managed and reviewed aging complaints to prioritize and expedite resolution timelines.
- Handled logging, reviewing, and processing of customer complaints.
- Provided timely responses to customer requests, ensuring clarity and resolution of issues.
- Prepare MDR reports and submit to FDA and other competent authority (EU and Health Canada).
- Understanding of FDA regulations for Class II and III critical care devices with regard to MDR and complaint handling.
- Monitor and investigate DEFOA Failures (Out Of Fox Failures) for trending purposes.
- Actively participates in QRB and MRM and provides feedback regarding product complaints and analysis of data.
- Engaged in external and internal audits.
- Engaged in recall activities.
- Assist customer in troubleshooting failure over the phone.
- Supported the training of new hires.
- Performed tasks to support team objectives and operations.
Sr. Complaint Analyst
TYCO/MALLINCKRODT
Carlsbad
01.1997 - 01.2003
- Applied FDA regulations for Class II and III critical care devices in MDR and complaint handling.
- Handled and processed complaints for products built and designed by TYCO/Mallinckrodt Carlsbad Division (7200, 840, Adult Star and Infant Star Ventilators).
- Prepare MDR reports and submit them to FDA.
- Participate in failure investigation of failed components or devices.
- Authored investigation reports, analyzed complaint events for trending, and facilitated regulatory reporting activities.
- Coached and trained new analysts on established procedures to enhance team knowledge and compliance.
- Provided technical assistance to customers to resolve product issues.
- Assisted team operations by completing additional tasks.
Production Lead / Rework Technician
Nellcor Puritan Bennett
Carlsbad
01.1992 - 01.1997
- Supervised 21 production employees on Main Assembly Line, ensuring adherence to quality standards.
- Ensure employees are following GMP and correct procedures.
- Assign daily tasks to employees.
- Trained employees on additional tasks to enhance workforce versatility.
- Assist in troubleshooting failing units.
- Conducted daily inventory control (Cycle Count) to maintain accurate stock levels.
- Perform weekly presentation of SPC chart.
- Attend daily MRB meetings.
- Ordered materials for daily production tasks.
- Responsibilities include conducting daily meetings.
Rework Failure Analysis
Puritan Bennett
Carlsbad
01.1987 - 01.1992
- Responsibilities include supporting production for ventilators.
- Troubleshot and repaired ventilator failures to restore functionality.
- Identified root causes of problems and documented non-conformance for corrective actions.
- Conduct final testing procedures to ensure product quality.
- Perform Quality inspections.
- Perform process audit.
- Set up test equipment.
- Maintain tools and test equipment within calibration.
- Assisted engineering department in resolving technical issues to support production goals.
- Attended Material Review Board meetings to address non-conformance issues.
Education
Supervisory Academy -
Mira Costa College
Oceanside, CA, USA01-2000
Bachelor's Degree -
San Sebastian College Recolletos
Philippines01-1987
Institute of Electronics and Technology -
Guzman Institute of Electronics and Technology
Philippines01-1983
High School -
Cavite National High School
Philippines01-1981
Skills
- Complaint investigation
- MDR reporting
- Regulatory compliance
- Regulatory audits
- Investigation techniques
- Quality assurance
- Data analysis
- Market trend analysis
- Customer relationship management
- Problem solving
- Attention to detail
References
References are available on request.
Timeline
Sr. Complaint Investigator
Philips/Respironics Inc.
08.2003 - 10.2025
Sr. Complaint Analyst
TYCO/MALLINCKRODT
01.1997 - 01.2003
Production Lead / Rework Technician
Nellcor Puritan Bennett
01.1992 - 01.1997
Rework Failure Analysis
Puritan Bennett
01.1987 - 01.1992
Supervisory Academy -
Mira Costa College
Bachelor's Degree -
San Sebastian College Recolletos
Institute of Electronics and Technology -
Guzman Institute of Electronics and Technology
High School -
Cavite National High School