COLLETTE N. CABRERA
Arlington,TN
Summary
Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Bringing many years of experience and seeking a growth-oriented position.
Overview
15
15
years of professional experience
Work History
Market Quality Technician III
Olympus Surgical Technology of America
11.2020 - Current
- Ensured that all materials meet required specifications before releasing them for use in production.
- Supported the review of updated technical and standards to ensure continued compliance.
- Conducted investigations on product complaints and generated documentation for regulatory agency submissions.
- Efficient and timely reporting of monitored complaints ensured.
- Gathered, evaluated and managed information in diverse formats.
- Managed necessary processes for international registration activities.
- Supported regulatory audits, ensuring compliance with required standards and procedures.
- Tracked defect trends to identify areas for enhancing manufacturing process.
- Investigated customer complaints regarding product defects and deviations from specified requirements.
- Performed root cause analysis to identify corrective actions for non-conforming parts, effectively communicating findings to management.
- Provided technical support for product quality issues across multiple departments.
- Trained individuals in laboratory procedures, regulatory policies, and physical devices inspections.
- Maintained unwavering commitment to excellence by paying meticulous attention to detail.
Endoscope Technician/Trainer
Olympus Surgical Technology of America
Bartlett, TN
10.2017 - 11.2020
- Performed troubleshooting and repair of equipment in accordance with manufacturer specifications.
- Maintained records of repairs, calibrations, and tests performed on equipment.
- Utilized a variety of hand tools including soldering irons, screwdrivers, pliers, cutters, wire strippers and crimpers.
- Diagnosed problems using test equipment such as multimeters, oscilloscopes, signal generators, power supplies.
- Tested and calibrated instruments to ensure accuracy and reliability of data.
- Replaced defective components or parts as needed.
- Managed quality control and maintained high level of customer satisfaction.
- Followed safety practices to safeguard against injury and damage to property.
- Troubleshot malfunctions and diagnosed issues to service equipment quickly and fully.
- Filled out work orders, repair logs and maintenance plans to document work completed.
- Routinely inspected equipment for preventive and emergency maintenance needs.
- Adapted teaching methods according to the needs of individual learners or groups.
- Maintained up-to-date records of trainee progress and provided regular updates to management team.
- Provided feedback on employee performance based on observed results during training sessions.
Respiratory Therapist
Pulmonary Medicine & Critical Care
Memphis, TN
08.2009 - 06.2017
- Managed heavy daily patient volume by handling telephone triage, appointment scheduling, and oxygen equipment.
- Skilled at accurately managing documentation, records, and paperwork with a focus on maintaining patient confidentiality.
- Performed patient triage and documented vital signs such as weight, blood pressure, pulse, and temperature in electronic patient charts.
- Maintained appropriate stock levels of medical supplies for exam rooms, performed routine instrument maintenance, and adhered to sterilization protocols.
- Maintained all necessary logs and conducted quality checks for various items such as refrigerator temperatures, emergency medications, expired medications, oxygen levels, and cold sterilization fluid changes.
- Monitored patient progress and adjusted treatments for optimal effectiveness.
- Ensured all regulatory requirements were met within scope of practice guidelines set forth by governing agencies.
- Coordinated patient care by interacting with patients, family members, and physicians.
- Determined patient safety risks to identify medical intervention needs.
- Conducted EKGs, stress testing or lung capacity tests to evaluate patients' cardiopulmonary functions.
- Administered medication, monitored vital signs and assisted in the delivery of medical gases to patients.
- Tracked changes in blood chemistry, vital signs and other markers of improvement or decompensation in critically ill patients.
- Maintained patient airways with endotracheal intubation.
Education
Associate Degree in Applied Science -
Concorde Career College
Memphis, TN07-2009
Diploma, Medical Assistant program - Medical Laboratory Technology
Remington College
Memphis, TN10-2004
Skills
- Quality assurance tools and methodologies
- Kaizen / 5 Whys
- Root Cause Analysis
- Calibration
- Controlled
- Test Equipment
- Hand soldering
- Written and Communication skills
- Reading and following manuals
- Microsoft Office
- Problem Solving
- Data Collection
- Internal/External Audits
- Self-Motivation
- Time Management
- International Regulations
- Physical device evaluation
- ETQ, Agile, SAP, Datasweep, Salesfore, Oracle systems
- Basic NCR and CAPA knowledge
Timeline
Market Quality Technician III
Olympus Surgical Technology of America
11.2020 - Current
Endoscope Technician/Trainer
Olympus Surgical Technology of America
10.2017 - 11.2020
Respiratory Therapist
Pulmonary Medicine & Critical Care
08.2009 - 06.2017
Associate Degree in Applied Science -
Concorde Career College
Diploma, Medical Assistant program - Medical Laboratory Technology
Remington College
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