Job Search Status
Open to workDesired Job Title
Director, Q&RAQuality ManagerQuality Assurance Assistant DirectorWork Type
Full TimeLocation Preference
RemoteHybridLocation: USSan Antonio, TX
Open to relocation: No
Open To Work
Kimberly J. Jimenez
Work Preference
Summary
Strategic quality management professional specializing in healthcare software compliance and risk management. Expertly collaborated with R&D and global teams, implementing quality systems that support regulatory standards and drive operational excellence, resulting in enhanced product quality and process efficiency.
Overview
12
12
years of professional experience
Work History
Director, Q&RA
Gpi USA
07.2021 - 01.2025
- Directed product release authorization, achieving 30% annual increase in software releases and successful FDA 510(k) submission
- Managed regulatory compliance as the Management Representative (21 CFR 820) and upheld quality across Gpi USA's medical device software products.
- Aligned stakeholders to integrate preventive quality controls into processes and procedures, enhancing overall compliance and risk management
- Developed and maintained systems for tracking issues, deviations, CAPAs, and quality events across processes, protocols, and procedures and analyze trends to identify potential systemic issues
- Led risk management activities and root cause analysis for quality events
- Conducted internal and external QMS audits
- Cultivated a quality-focused culture through guidance, best practices, and training for functional teams, reinforcing high-quality standards
- Collaborated with R&D teams to review project deliverables across entire software development lifecycle from charter to post market surveillance activities aligned with ISO 13485:2016 Medical Devices - Quality Management Systems, QMS, and Quality by Design (QbD)
- Spearheaded the ISO 37001:2025 Anti-bribery management systems implementation for the US
- Collaborated with IT and CISO to obtain TX-RAMP and SOC 2 Type 2 certifications aligned with ISO 27001:2022 Information Security Management Systems
- Supported process impact assessment process, reviewing new and revised SOPs prior to authoring to assess impact, risk, alignment with industry trends, and regulatory requirements
- Collaborated with global teams to bring healthcare software solutions to the US market
Quality Manager
Gpi USA
02.2021 - 07.2021
- Lead development and maintenance of total Quality Management System (QMS) to ensure compliance to regulations and standards
- Developed risk assessment mitigation plans through FMEA
- Liaised with company and customers on quality matters to address concerns and improve satisfaction
- Established procedures and quality metrics to enhance compliance and performance monitoring
- Managed change control and supplier management to ensure alignment with quality standards and requirements
- Conducted internal and external QMS audits
Project Manager
Haemonetics and Gpi USA
01.2017 - 02.2021
- Managed daily project operational aspects to include project plans, process flows, RACI charts, work instructions and standard operating procedures (SOP)
- Led a cross-functional project team, addressing their inquiries and ensuring project deliverables aligned with business objectives.
- Identified process improvements that mitigated risks, minimized project delays, and ensured timely, within-budget project execution
- Facilitated collaboration among teams to ensure successful software implementation
- Collaborated with customer stakeholders to understand priorities and evaluate delivery options
- Created and successfully executed work plans and documentation for software implementation projects
- Developed change management plans to facilitate efficient project execution
- Oversaw project scope, meticulously planned, controlled, and scheduled all project activities
- Provided onsite process reviews, implementation support and troubleshooting
- Presented and provided software training to customers
- Communicated feedback to all team members throughout project lifecycle
- Delivered financial value to customers and organization by aligning project outcomes with business goals
- Built knowledge base of customer’s business, organization, and objectives
- Developed BECS stage environments based on customer requirements and industry regulations
- Delivered expert guidance on industry practices
Quality Assurance Assistant Director
South Texas Blood & Tissue Center (STBTC)
07.2014 - 01.2017
- Led strategic initiatives for Quality Assurance department to align with organizational goals and improve operational standards
- Planned, directed, organized, managed all operations of the Quality Assurance department
- Drove STBTC's quality and regulatory training program adhering to BioBridge Global's quality program directives
- Oversaw the deviation reporting system and ensured 100% on time submission of all FDA reportables
- Monitored regulatory compliance in all areas of the blood operations
- Managed quality performance data collection for STBTC leadership review to ensure the business unit meets quality requirements, quality objectives, and maintain quality system integrity
- Assessed, monitored and reviewed complex deviations, CAPAs, and quality events
- Managed program to confirm technical/complex STBTC staff competencies are maintained by STBTC operations leadership
- Managed customer communications on quality events and regulatory actions to maintain stakeholder trust and transparency
- Oversaw management of STBTC site master file, equipment master file, design history files and data for review by regulatory agencies, customers, and accreditation inspections
- Provided equipment, process, and software validation assessment and oversight for qualification as part of STBTC change control management
- Ensured maintenance of library of registrations, certificates, and licensures for STBTC
- Coordinated external audits, validations, quality control records, proficiency surveys, and corrective actions to uphold safety and integrity of blood supply
- Prepared annual departmental budgets
- Hired, terminated, promoted, demoted, oriented, evaluated, counseled, and managed salary changes for departmental personnel.
QA Specialist- Software Administration
South Texas Blood & Tissue Center
06.2013 - 07.2014
- Configured, validated, and maintained quality related software applications to ensure compliance with regulations
- Maintained quality related software applications in accordance with applicable regulations and standards
- Developed and reviewed Standard Operating Procedures (SOPs) to standardize quality practices
- Guided other departments in the development and preparation of SOPs
- Assisted other departments in establishing calibration protocols and maintenance records in accordance with cGMP and/or regulatory requirements
- Executed internal audits to ensure compliance with quality standards
- Performed Quality Control review for batch release of blood products
- Supported external audits by providing necessary documentation and insights
- Conducted training sessions and provided mentorship for new employees to ensure proper onboarding
- Created process improvement projects aimed at enhancing operational workflows
- Led implementation of ElDorado Donor (blood establishment computer software) to enhance operational efficiency
- Facilitated ISBT (industry barcoding) conversion
Education
Certificate - Medical Device Quality Management Systems ISO 13485:2016, Management Systems Auditing ISO 19011:2018, Leading Management Systems Audit Teams ISO 19011: 2018
BSI
LEAN Six Sigma Red Belt Training - Black Belt for Bloodbanking Industry
BioBridge Global
LEAN Six Sigma Green Belt Certificate -
BioBridge Global
Post-Baccalaureate Diploma - Clinical Laboratory Science
University of Texas Health Science Center
Bachelor of Science - Biology
St. Mary's University
San Antonio, TXSkills
- Quality management systems
- Management systems auditing
- Compliance Management
- Regulatory Standards
- Quality Improvement
- Quality Analytics
- Risk Assessment
- Process Optimization
- Process implementation
- Corrective Action
- Audit team leadership
- Stakeholder Engagement
- Change management
- Continuous improvement
- Leadership
- Collaboration
- Risk Management
- Strategic Thinking
- Problem Solving
- Adaptability
- Client Focused
- Atlassian Jira tracking
- Atlassian Jira service
- Salesforce cloud
- Communication
- Training Development
- Quality Systems
References
Available upon request.
Software Experience
e-Delphyn Donor, e-Delphyn Lab, ElDorado Donor, DonorDoc, Hemasphere, Surround, eDonor, WebLab MDW, Quality Records, HemaComply, HemaControl, Jira Product & Issue Tracking, Service Management, Service Cloud, SmartCAPA, Quality Management
Timeline
Director, Q&RA
Gpi USA
07.2021 - 01.2025
Quality Manager
Gpi USA
02.2021 - 07.2021
Project Manager
Haemonetics and Gpi USA
01.2017 - 02.2021
Quality Assurance Assistant Director
South Texas Blood & Tissue Center (STBTC)
07.2014 - 01.2017
QA Specialist- Software Administration
South Texas Blood & Tissue Center
06.2013 - 07.2014
Certificate - Medical Device Quality Management Systems ISO 13485:2016, Management Systems Auditing ISO 19011:2018, Leading Management Systems Audit Teams ISO 19011: 2018
BSI
LEAN Six Sigma Red Belt Training - Black Belt for Bloodbanking Industry
BioBridge Global
LEAN Six Sigma Green Belt Certificate -
BioBridge Global
Post-Baccalaureate Diploma - Clinical Laboratory Science
University of Texas Health Science Center
Bachelor of Science - Biology
St. Mary's University