Luz Dayana Ortiz Jerez
Summary
Dynamic quality assurance professional with proven track in medical device industry, ensuring high standards in product and process integrity.
Strong focus on team collaboration and delivering results, adaptable to changing needs. Expertise in quality control methodologies, regulatory compliance, and continuous improvement initiatives. Known for reliability, problem-solving abilities, and effective communication.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Quality Operations Manager
BBraun Medical
04.2022 - Current
- Supervised operations staff and kept employees compliant with company policies and procedures.
- Review and approval of Quality SOPs and records fostering regulatory and company policies compliance.
- Conducted regular performance reviews, identifying areas for improvement and developing action plans to address them. Empowered employees to take ownership of their responsibilities, leading to increased accountability and improved performance outcomes.
- Collaborate with supply chain team oversight inventory and operations to achieve timely and accurate delivery of goods and services.
- Enhanced customer satisfaction by establishing clear communication channels and addressing concerns promptly.
- Analyzed and reported on key performance metrics to senior management.
- Led/support successful change initiatives, ensuring seamless transitions during organizational restructuring efforts.
Senior Quality Process Control Supervisor
BBraun Medical
2021 - 2022
- Oversaw the development of custom software applications designed to enhance overall plant efficiency through real-time monitoring and reporting capabilities.
Senior Document Control/Product Release Supervisor
BBraun Medical
2014 - 2021
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows.
- Oversaw daily operations of the department, ensuring smooth workflow and timely completion of tasks.
- Collaborated with other departments to achieve organizational goals, fostering teamwork across various functions.
Audit Tracking & CAPA Analyst
BBraun Medical
2008 - 2014
- Collaborated with cross-functional teams to identify opportunities for process improvement and increased efficiency.
- Improved internal knowledge sharing by developing comprehensive documentation outlining standard operating procedures for various tasks.
- Enhanced team collaboration by providing clear communication of complex findings through visualizations and reports.
- Implemented predictive analytics techniques that enabled proactive adjustments to business strategies based on emerging trends.
Document Control Coordinator
BBraun Medical
2004 - 2008
- Scanned, filed and transmitted various documents and adhered to digital filing procedures.
- Evaluated current document processes, suggested methods for change and implemented successful improvements.
- Checked blueprints and drawings for accuracy and completeness.
- Expedited retrieval of archived files for legal matters or audits through effective indexing methods and diligent record-keeping practices.
- Improved interdepartmental communication and collaboration by conducting regular training sessions on document control procedures.
- Developed comprehensive procedural manuals to guide employees in proper document handling practices, reducing errors and inconsistencies in record maintenance.
- Assisted in the implementation of software upgrades to improve overall document management capabilities within the organization.
- Established clear document retention schedules in accordance with industry guidelines and company policies, minimizing unnecessary storage costs while ensuring access to vital records.
- Contributed to successful audits by maintaining complete and organized documentation archives, demonstrating adherence to industry regulations and internal guidelines.
- Collaborated with IT department members to resolve technical issues related to document storage systems, ensuring uninterrupted access for authorized users.
Education
Bachelor of Science - Marketing
UNAPEC
Santo Domingo, Dominican Republic01-2005
Skills
- Problem-solving
- Decision-making
- Root-cause analysis
- CAPA Implementation
- Teamwork and collaboration
- Critical thinking
- Audit process management
- SAP Management
Certification
- Certified Quality Auditor - American Society for Quality (ASQ)
- Six Sigma Green Belt - BBraun
- Master Bronze Lean Manufacturing Training - Quantum TC
- Internal Auditor ISO13485:2016 - Supremas Qualitas
Languages
English
Professional Working
Spanish
Native or Bilingual
Timeline
Quality Operations Manager
BBraun Medical
04.2022 - Current
Senior Quality Process Control Supervisor
BBraun Medical
2021 - 2022
Senior Document Control/Product Release Supervisor
BBraun Medical
2014 - 2021
Audit Tracking & CAPA Analyst
BBraun Medical
2008 - 2014
Document Control Coordinator
BBraun Medical
2004 - 2008
Bachelor of Science - Marketing
UNAPEC
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