Katrina Bless Real
Carrollton,TX
Summary
Diligent Quality professional skilled in optimizing Quality Management System processes, reducing rates of non-conformances and driving compliance in stringent ISO 13485 and FDA regulated environments. Known for leading successful teams/projects by driving continuous improvement through KPIs and standardized practices. Adept at collaborating across departments, across all levels from employees to upper management, to ensure sustainable implementations and long-term organizational growth.
Overview
15
15
years of professional experience
Work History
Quality Manager
Steri-Tek
04.2022 - Current
- Collaborated with Steri-Tek Headquarters to ensure new facility complied to ISO standards, applicable regulatory requirements and the company Quality Management System. Achieved ISO 13485 certification within first three (3) months of opening the facility. Successfully worked with a small team to build the new facility from the ground up, scaling from three (3) to forty-four (44) employees over a three-year period.
- Successfully interviewed, hired, onboarded, trained and managed a team of nine (9) Quality personnel. Performed employee evaluations, tracked career progress and documented formal performance reviews.
- Collaborated with Steri-Tek Headquarters for evaluation and implementation of a new electronic QMS system. Updated work instructions and overall structure of the Quality Management System to ensure smooth transition.
- Created and reported daily, bi-weekly and monthly KPIs to report the health of the Quality department across the organization. Collaborated and participated in Management Review meetings to report the effectiveness of the Quality Management System.
- Reduced non-conformance rate by ~25% from the first year of business through standardization of non-conformance practices, implementation of corrective actions, collaboration across departments for continuous improvement and implementation of a robust training program. Created and implemented Special Orders and Requests Team to reduce the overall rate of processing related non-conformances by 50%.
- Authored, reviewed and approved QMS documentation such as Work instructions, standard operating procedures, and forms through the Change Control process. Review and approval of Quality documentation such as Quality Agreements, validation reports, processing specifications, etc.
- Served as the primary host for over 50 external audits/inspections, including facility preparations and audit responses for closure. Reduced overall audit findings by 88% from the first year of business by coordinating continuous improvement efforts across departments and standardizing audit practices.
Quality Specialist
Steri-Tek
12.2020 - 04.2022
- Reviewed approximately 5-10 batch records daily during quality inspections for accuracy and completeness. Resolved any discrepancies in a timely manner to ensure both product specifications and production schedules were met.
- Reviewed and approved Dose Map Reports for completeness and accuracy before sending to the customer for final approvals.
- Maintained internal Standard Operation Procedures (SOPs) and Work Instructions (WIs) through document control system utilizing the Steri-Tek database.
- Provided timely support to during preparation of and hosting of customer audits (Approximately 3-5/month).
- Supported and documented the investigations and corrections for core Quality functions, such as CAPAs, Complaints, and Non-Conformances.
- Maintained calibration and preventive maintenance logs. Scheduled necessary activities with suppliers.
- Assisted Quality Manager in maintenance of the Quality Management System (QMS) as needed.
- Maintained up-to-date knowledge on relevant regulations within the industry, ensuring company practices remained compliant at all times.
Administrative Assistant (Part-Time)
Steri-Tek
04.2020 - 05.2020
- Reported to the Chief Executive Officer (CEO) and completed administrative work efficiently.
- Managed the return of customer product utilized for the development of product specifications.
- Maintained confidentiality of sensitive information by adhering to strict privacy policies and implementing secure filing systems.
Bartender
Chili's
05.2016 - 11.2020
- Took customer orders, tracked order quality, and ensured the satisfaction of up to 15 groups of customers at a time.
- Maintained cleanliness and organization of the bar area, ensuring compliance with health regulations.
- Fostered a welcoming environment for diverse clientele and coworkers by demonstrating cultural sensitivity when interacting with people from different backgrounds.
- Trained new employees on service standards and operational procedures as head trainer.
Shift Manager
Tpumps
03.2013 - 01.2015
- Assisted in scheduling team members to ensure coverage of three shifts, and managed teams of up to 15 people on a shift.
- Attended weekly management trainings and reported sales, labor, and relevant reports.
- Collaborated in promotional efforts and implemented them across different sites.
- Streamlined operational processes, fostering a culture of continuous improvement within the team.
- Trained new employees on company policies, procedures, and job responsibilities, ensuring seamless integration into the team.
Peer Health Exchange Leadership Council Member
San Francisco State University Chapter
08.2010 - 04.2014
- Taught a peer-based comprehensive health education curriculum on a weekly basis to diverse populations of bay area high school students in classes up to 30 students.
- Attended ongoing trainings to improve teaching/facilitation skills, classroom management and social justice philosophies.
- Managed a cohort of three student health educators and provided assistance/resources for curriculum, classroom management, and logistics.
Education
BS - Health Education, Community Health emphasis
San Francisco State University
CA01.2014
Skills
- Audit preparation and hosting (ISO 13485 Lead Auditor certified)
- ISO Standard knowledge & Regulatory Requirements
- Investigation and Root Cause Analysis
- Continuous Improvement
- Process development
- Validation documentation
- Corrective actions
- Project Management
- eQMS & ERP System implementation
Timeline
Quality Manager
Steri-Tek
04.2022 - Current
Quality Specialist
Steri-Tek
12.2020 - 04.2022
Administrative Assistant (Part-Time)
Steri-Tek
04.2020 - 05.2020
Bartender
Chili's
05.2016 - 11.2020
Shift Manager
Tpumps
03.2013 - 01.2015
Peer Health Exchange Leadership Council Member
San Francisco State University Chapter
08.2010 - 04.2014
BS - Health Education, Community Health emphasis
San Francisco State University