Sandra Huerta
Noblesville,IN
Summary
Seeking a position that will utilize my talent in Quality to uphold company standards and create growth.
Quality professional with proven track record in maintaining stringent quality standards and improving operational processes. Valued for excellent team collaboration and achieving reliable results. Recognized for adaptability, critical thinking, and precision in inspection tasks.
Overview
14
14
years of professional experience
Work History
Senior Incoming Quality Assurance Inspector
Abbott
08.2012 - 11.2018
- Train/ inspect parts per Material Specifications.
- Proficient in the use of hand tools and optical measurement systems.
- Experienced with daily usage of SAP.
- Initiate CAPA’s through CATSWeb.
- Performed routine testing and analysis of Supplier certificates to identify defects and nonconformities.
- Participated in continuous improvement initiatives aimed at optimizing quality control procedures.
- Communicate with Supplier Quality Engineers for certification issues.
- Overtook ownership of archiving records.
Quality Control Inspector Lead
Abbott
11.2018 - 05.2022
- Conducted thorough inspections of finished products to ensure compliance with quality standards.
- Collaborated with production teams to identify defects and implement corrective actions to reduce rework.
- Trained new inspectors on quality control procedures and equipment usage for improved team performance.
- Directed a team of inspectors, establishing weekly schedules to optimize production output efficiency.
- Reviewed electronic batch records meticulously and provided training to enhance team proficiency in documentation processes.
Senior Quality Assurance Specialist
Abbott
05.2022 - 09.2024
- Reviewed and approved manufacturing and quality documentation to ensure compliance with FDA, GMP, and internal quality system requirements.
- Partnered with Manufacturing, Engineering, and Quality Control teams to resolve quality issues and support timely product release.
- Supported change control activities, including assessment of quality impacts and implementation of procedural updates.
- Prepared and completed documentation to send finished product for sterilization.
- Assessed sterilization certificates to guarantee adherence to regulatory requirements for product safety.
- Conducted comprehensive audits to identify areas for process improvement and risk mitigation.
Quality Supervisor
Abbott
09.2024 - Current
- Developed and monitored quality KPIs including lot review turnaround time, documentation accuracy and process monitoring performance.
- Led implementation of procedural improvements to strengthen sterilization process controls and documentation compliance.
- Evaluated quality events related to manufacturing and sterilization operations and approved product disposition decisions.
- Supported regulatory inspections and internal audits.
- Contributed to quality management review board as a panel member.
- Managed CAPA activities from initiation through effectiveness.
- Monitored and reported quality metrics, identifying trends and implementing actions to improve performance.
Education
High School -
Foothill High School
Pleasanton, California01-2007
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Las Positas Community College
Livermore, CaliforniaSkills
- Quality inspections
- Quality management
- File management
- Defect tracking
- Root Cause Analysis
- Batch Record Review
- Sterilization Process Oversight
- Change Control
- Team Leadership
- Trend Analysis
- Cross-Functional Collaboration
- Good Documentation Practices (GDP)
Timeline
Quality Supervisor
Abbott
09.2024 - Current
Senior Quality Assurance Specialist
Abbott
05.2022 - 09.2024
Quality Control Inspector Lead
Abbott
11.2018 - 05.2022
Senior Incoming Quality Assurance Inspector
Abbott
08.2012 - 11.2018
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Las Positas Community College
High School -
Foothill High School