MARIELLA ORDOÑEZ
Laguna Niguel,United States
Summary
Quality Systems leader with expertise in the manufacturing and servicing sectors of the Medical Device Industry. Proficient in Quality Management Systems focused on ISO 13485:2016, ISO 14971:2019, 21 CFR Part 803, 806, 820, UK MDR 2002, EU MDR (2017/745), global and MDSAP related standards/regulations. Developed and implemented quality management systems that remediated FDA 483s and supported continuous improvements to enhance compliance in alignment with business initiatives.
Overview
2
2
Languages
1
1
Certification
10
10
years of professional experience
Work History
Quality Systems Manager
Applied Medical Resources Corporation
Rancho Santa Margarita, CA
2025.01 - Current
- Provides strategic leadership for Purchasing & Supplier Control activities to ensure local and global compliance while driving continuous improvement initiatives aligned with quality objectives.
- Establishes, monitors, and analyzes metrics related to supplier and internal team performance to drive continuous improvement initiatives.
- Establishes and revises procedures to maintain alignment to applicable standards and regulatory requirements.
- Reviews and approves supplier qualifications, re-evaluations, notifications, audits, and item qualifications.
- Facilitates and supports cross-functional team projects to promote collaboration and efficiency.
- Mentors team members to enhance skill development, fostering independent contributors and prospective leaders.
Internal Auditor
Applied Medical Resources Corporation
Rancho Santa Margarita, CA
2022.01 - 2025.01
- Established yearly internal audit schedule based on business needs and risk assessment outcomes.
- Prepared internal audit plans to ensure identification of regulations and processes.
- Conducted audits utilizing interviews and statistical assessments for compliance verification.
- Assessed previous audit findings to inform current evaluations and practices.
- Developed and revised procedures, improving internal audit system efficiency and compliance.
- Compiled and presented metrics to monitor internal audit system effectiveness.
- Compiled and presented internal audit metrics, enabling effective monitoring of system performance.
- Performed nonconformance grading per GHTF SG3 N19:2012 QMS for regulatory compliance.
- Organized schedules and facilitated communication with notified bodies, ensuring successful execution of external audits.
- Facilitated continuous improvement initiatives in partnership with CAPA team and executive management.
Sr. Quality Analyst & Lead Auditor
Avante Health Solutions
San Clemente, CA
2018.03 - 2021.12
- Provided strategic leadership for the Quality Assurance and Regulatory Affairs (QA/RA) department ensuring compliance in accordance with FDA regulations (21CFR Part 803, 806, and 820) and ISO standards (ISO 13485:2016, ISO 9001:2015, and ISO 14971:2016) while driving continuous improvement aligned with quality and business initiatives.
- Led successful remediation of three out of six FDA 483 observations, coordinating efforts and ensuring timely resolution as Project Lead.
- Functioned as the main liaison with the FDA during remediation and coordinated the submission of updates to the FDA throughout and following remediation.
- Established annual internal audit programs and conducted audits per ISO 13485:2016.
- Served as main point of contact for regulatory/notified bodies and audit facilitator for customer and external audits.
- Managed CAPA, purchasing & supplier controls, nonconformance controls, and post-market surveillance processes to uphold quality standards and regulatory compliance.
- Established and analyzed QA/RA and external department metrics in collaboration with executive leadership across multiple sites to enhance compliance tracking.
- Established and revised procedures to maintain continued alignment with applicable standards and regulatory requirements.
- Facilitated and supported cross-functional team projects to evolve business practices while maintaining compliance, providing QA/RA education to team members, and maintaining alignment of company culture.
Quality Analyst
Avante Health Solutions
San Juan Capistrano, CA
2017.07 - 2018.03
- Maintained compliance with ISO 9001 and ISO 13485 through complaint and document control activities.
- Monitored production and service control metrics for quality assurance.
- Implemented continuous improvement initiatives, resulting in three percent reduction in warranty data across eight servicing departments.
- Facilitated cross-functional projects to define processes that ensured successful ERP implementation.
- Coordinated ERP implementation activities during go-live and post-launch phases.
- Designed service and sales production platforms for ERP system compliant to quality standards.
- Developed and implemented company-wide training programs; led training sessions for ongoing employee development.
Engineering Manager Assistant
Avante Health Solutions
San Juan Capistrano, CA
2017.01 - 2017.06
- Supported Engineering Manager with administrative tasks for Quality Department, ensuring compliance and efficiency.
- Compiled monthly, quarterly, and yearly trend reports to highlight potential areas for reducing and sustaining warranty rates.
- Manually collected, trended, analyzed monthly metrics related to 350+ warranty service devices.
- Documented and analyzed customer complaints, identifying recurring issues to inform quality improvements.
- Obtained and maintained OEM service documentation for six servicing departments.
- Worked as a Service Technician to repair medical devices against OEM service manuals.
Education
A.S. - Psychology
Saddleback College
Mission Viejo, CASkills
- Strategic leadership and planning
- Global regulatory compliance
- FDA remediation
- Project management
- Cross-functional collaboration
- Compliance auditing
- Process optimization
- Root-cause analysis
- Emotional intelligence
Certification
- Fundamentals of Medical Device Awareness Single Audit Program (MDSAP), TUV SUD
- EU MDR: Medical Device Regulations, PharmOut
- ISO 14971:2019 Risk Management for Medical Devices, BSI
- ISO 13485:2016 Lead Auditor (TPECS), BSI
- MD - Medical Devices Quality Management Systems ISO 13485:2016, BSI
- AU - Management Systems Auditing (ISO 19011:2018), BSI
Languages
English
Native/ Bilingual
Tagalog
Native/ Bilingual
Timeline
Quality Systems Manager
Applied Medical Resources Corporation
2025.01 - Current
Internal Auditor
Applied Medical Resources Corporation
2022.01 - 2025.01
Sr. Quality Analyst & Lead Auditor
Avante Health Solutions
2018.03 - 2021.12
Quality Analyst
Avante Health Solutions
2017.07 - 2018.03
Engineering Manager Assistant
Avante Health Solutions
2017.01 - 2017.06
A.S. - Psychology
Saddleback College