Ethel Gijon
Oceanside
Summary
Senior Supervisor with extensive experience at Tandem Diabetes Care Inc., excelling in compliance and process improvement. Proven track record in mentoring teams and enhancing operational efficiency. Skilled in data analysis and decision-making, successfully implementing cost-saving initiatives while ensuring regulatory compliance and product quality.
Overview
10
10
years of professional experience
Work History
Senior Supervisor, Global Post Market Surveillance
Tandem Diabetes Care Inc.
San Diego, CA
01.2020 - Current
- Knowledge of ISO, FDA, and GMP concepts and guidelines with regards to MDR, complaint handling, reporting and corrective/ preventative actions.
- Strong comprehension of the use of devices, environment of use and ability to determine if reported issue and complaint is reportable based on FDA and International regulations.
- Updated work instructions and procedures upon released of new FDA and international regulations.
- Oversaw daily operations, ensuring compliance with quality standards and regulatory requirements.
- Mentored team members, fostering professional development and enhancing team performance.
- Implemented process improvements, increasing operational efficiency and reducing overtime.
- Coordinated cross-functional teams to drive project initiatives and streamline workflows.
- Developed training materials to support staff onboarding.
- Analyzed performance metrics to identify trends and recommend actionable strategies for improvement.
- Interviewed, hired and trained staff and provided ongoing feedback and performance evaluations for development.
- Enhanced team productivity by implementing efficient workflow processes and providing consistent guidance.
- Implemented cost-saving initiatives, reducing operational expenses without compromising quality or productivity.
Specialist Global Post Market Surveillance
Tandem Diabetes Care Inc.
San Diego, CA
06.2016 - 01.2020
- Responsible for end to end medical device complain handling processes building upon existing complaint management knowledge, including detailed analysis of each unique complaint scenario to determine the correct reportability to applicable regulatory agencies.
- Completed FDA reports, Health Canada MDPRs, European Manufacturer Incident Reports and TGA adverse event reports for adverse event reporting.
- Collaborated with cross-functional teams to enhance product quality and user experience.
- Assisted in developing training materials for new product launches and updates.
- Streamlined documentation processes, ensuring compliance with regulatory standards and internal policies.
- Collaborated with cross-functional teams to achieve project goals on time.
Education
Bachelor of Science - Biology
University of California, Riverside
Riverside, CA06.2014
Skills
- Innovation skills
- Data analysis
- Staff oversight
- Employee supervision
- Compliance
- Decision-making
- Process improvement
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Senior Supervisor, Global Post Market Surveillance
Tandem Diabetes Care Inc.
01.2020 - Current
Specialist Global Post Market Surveillance
Tandem Diabetes Care Inc.
06.2016 - 01.2020
Bachelor of Science - Biology
University of California, Riverside