Summary
Overview
Work History
Education
Skills
Websites
Certification
References
References
Timeline
Generic

Regina Thomas

Rockledge,FL

Summary

Accomplished Software Quality Assurance Engineer, adept in Quality System Software Management, and regulatory compliance. Proven track record in leading validation projects, enhancing process efficiency, and mentoring teams. Strong analytical skills and attention to detail drive successful outcomes in complex environments, ensuring adherence to FDA and ISO standards. Registered Nurse experience allows me to provide a clinical perspective to the projects that I work on.

Overview

35
35
years of professional experience
1
1
Certification

Work History

Software Quality Assurance Engineer

Philips Healthcare
01.2016 - 01.2025
  • Managed System Development Lifecycle Methodology (SDLM) deliverables and activities from planning to retirement to ensure compliance with regulations, procedures, Quality System processes and methodologies including documentation and reporting of validation activities.
  • Authored, reviewed and approved validation document deliverables per System Development Lifecycle Methodology (SDLM).
  • Managed 67 applications (including SaaS/cloud-based), with approximately one-third of those requiring full validation efforts and monitoring to ensure that systems remained in a validated state for their intended use, upcoming validation related activities, infrastructure qualifications and potential validation related improvements.
  • Maintained communication with team members, Business Process Owners and upper management to ensure lean and efficient planning of validation activities.
  • Facilitated application of controls and risk management by reviewing and approving IT change-control requests to assess potential quality system impact.
  • Provided GxP-related quality assurance mentoring, oversight, guidance, support and interpretation, to team members with emphasis on software validation in their validation efforts, to ensure compliance; recommend appropriate corrective actions where needed.
  • Supported regulatory and internal audits by providing validation documentation and subject matter expertise during inspections.

Software Quality/Regulatory Validation Engineer

Philips Healthcare
01.2012 - 01.2016
  • Lead project teams to ensure timely completion of validation deliverables.
  • Participated in Validation Life Cycle of regulated projects including application requirements, risk assessments, traceability matrix, validation testing and working closely with project teams to ensure accuracy, completeness and compliance of validation deliverables of IT applications in a regulated industry.
  • Authored validation deliverables ensuring accuracy, completeness and compliance to regulatory requirements and corporate policies and procedures.
  • Provided guidance/feedback to IT and Business groups in Validation compliance as per applicable regulatory requirements and corporate policies and procedures.
  • Supported internal/external audits and regulatory inspections from a validation perspective by providing validation expertise and documentation.
  • Recommended and lead Corrective and Preventive Actions (CAPAs) to improve validation practices.
  • Implemented improvements to validation while adhering to regulatory validation requirements, company QMS procedures, and industry best practices.

Sr. Quality Manager, PH Quality Systems

Philips Healthcare
01.2009 - 01.2012
  • Provided guidance to ensure compliance of processes and tools, including creation of policy and process documentation covering distribution, installation and servicing, post-marketing surveillance, trackability and traceability.
  • Developed and implemented assigned global strategic objectives for Quality System harmonization via process development, optimization, and harmonization as well as policy, process, and tool development, implementation, and maintenance to increase revenue through improved business process efficiency.
  • Created and facilitated development of corporate level policies and procedures in conjunction with process owners and stakeholders to ensure compliance to regulations and to align with Business strategic initiatives and processes.
  • Monitored and analyzed key performance indicators, including trending, target setting and initiation of corrective actions.
  • Supported transition planning and integration implementation of newly acquired companies into Philips Healthcare's Quality System.
  • Lead or facilitated CAPA's for non-conformances in QMS process improvement activity.

Regulatory Compliance Manager

Philips Healthcare (previously Witt Biomedical)
01.2005 - 01.2009
  • Managed Regulatory Compliance team which included management of complaints, adverse event reporting, correction and removals, product risk management, CAPA's, RMA investigations and non-conforming materials.
  • Evaluation of customer feedback to determine if feedback met the criteria of a complaint. If determined to be a complaint, evaluated complaints for determination of reportable events and submitted reportable event to regulatory bodies within required timeframes.
  • Ensuring completion and accuracy of complaint record prior to closure. This included Customer Service/Field Service records, investigation of suspected hardware / software failure through collaboration with RMA/vendor and product design departments to determine root cause and reporting to regulatory bodies, if required.
  • Responsible for tracking and managing recalls. This included submission of reports to regulatory bodies, collaboration with RMA/vendor and product design departments to determine root cause and resolution of reported issue, determination of affected devices/software and customer list, notification of customers, tracking of recall status to ensure completion of recall in a timely manner.
  • Performed risk analysis (Failure Mode Effects Analysis) to determine if failure had been previously reported and whether FMEA covered failure or required updating.
  • Management and software validation of system used for complaint handling and other Quality System functions (e.g., Adverse Event Reporting, Recalls, CAPA, Receiving Inspections, Non-Conforming Materials, Device History Records, etc.).
  • Developed and maintained company policies and procedures affecting Regulatory Compliance area.
  • Lead or facilitated Corrective Action and Preventive Action (CAPA) for non-conformances in complaint, medical device reporting, recall processes.
  • Developed and delivered compliance training to new and current employees.
  • Participation in regulatory agency audits and internal audits including presentation of objective evidence for responses to auditing agency.
  • Preparation of reports for Management Review meetings and tracking of complaints, adverse event reports, correction & removals / recalls, system validation status.

Assistant Customer Support Manager

Witt Biomedical Corporation
01.2003 - 01.2005
  • Developed and maintained company policies and procedures affecting Customer Support area.
  • Managed Clinical Applications staff both in-house and onsite, including critical review of expense reports.
  • Taught software related Advanced User classes.
  • Support of customers to plan for implementation, configuration, questions and troubleshooting of hemodynamic and image computer systems.

Clinical Applications Specialist

Witt Biomedical Corporation
01.1998 - 01.2003
  • Developed and maintained Customer Support procedures and trained new Clinical Applications personnel.
  • Onsite clinical training of staff for electronic hemodynamic monitoring / image computer systems and troubleshooting techniques. Included training personnel on setup, use and maintenance of system and training on hemodynamics, cardiac rhythms, documentation of procedure notes, inventory used, hemodynamics, images, use of central station and bedside monitoring station.
  • Support of customers to plan for implementation, configuration, questions and troubleshooting of hemodynamic and image computer systems.

Registered Nurse

Methodist Hospital
01.1990 - 01.1998
  • 1996-1998: Clinical Educator for Cardiac Cath Lab, Cath Lab Holding Area, Telemetry, Echo, EKG and IV Team Staff. Included responsibility for creating and providing unit training, house-wide training, JCAHO and State Board of Health training. Created training blitz training material, planned training blitz, arranged with vendors to assist with training blitz, performed training and checkoffs for training blitz. Held CPR, ACLS and TB Instructor certifications. Also, responsible for maintaining documentation of these events for all staff.
  • 1993-1996: Cardiac Cath Lab RN. Patient care, scrub tech, procedural documentation, inventory control and traffic flow for diagnostic, intervention and electrophysiology procedures. Included angioplasty, stents, atherectomy, rotablator, ballon pumps, defibrillators, vascular closure devices, pacemakers, internal implantable defibrillators. Served as preceptor for new Cath Lab personnel.
  • 1990-1993: Worked as RN on cardiovascular surgical step-down unit. Cross-trained to both medical and surgical cardiovascular ICU's and worked in these areas as needed for coverage. Developed patient documentation for Managed Care post surgical patients as well as bedside documentation for house-wide patients.

Education

Bachelor of Science - Nursing

Indiana University
Indianapolis, IN
01.1995

Associate of Science - Nursing

Indiana University
Indianapolis, IN
01.1989

Skills

  • Program/Project Management
  • Quality System Software Management, Tool Development and Validation (including CSV/CSA)
  • Test case management, script development, execution, failure tracking and resolution
  • SDLM (GAMP5, Waterfall, Agile)
  • Post Market Surveillance including complaint handling, adverse event reporting, correction and removals/recalls
  • Medical Device Regulations (FDA, ISO, MDD, etc)
  • Corrective and Preventive Actions (CAPA)
  • Regulatory Compliance
  • Risk Management
  • Document / Change Control
  • Product and Process Improvement
  • Procedure and Process Development
  • Clinical Evaluations
  • Clinical Educator including training development
  • Problem solving / Analytical skills
  • Audit preparation and participation
  • Team leadership including communication / collaboration with multi-faceted teams and stakeholders
  • Strong attention to details
  • Microsoft Office (Word, Excel, Teams, PowerPoint, Outlook, Visio, Project)
  • Applications (ARIS, iServer, OpenText, Cornerstone, ValGenesis, AdobeSign, Windchill)

Websites

Certification

  • Certified Software Quality Engineer, American Society for Quality (ASQ), 2015
  • Quality System Certification, Association for the Advancement of Medical Instrumentation (AAMI), 2009

References

References are available on request.

References

References available upon request.

Timeline

Software Quality Assurance Engineer

Philips Healthcare
01.2016 - 01.2025

Software Quality/Regulatory Validation Engineer

Philips Healthcare
01.2012 - 01.2016

Sr. Quality Manager, PH Quality Systems

Philips Healthcare
01.2009 - 01.2012

Regulatory Compliance Manager

Philips Healthcare (previously Witt Biomedical)
01.2005 - 01.2009

Assistant Customer Support Manager

Witt Biomedical Corporation
01.2003 - 01.2005

Clinical Applications Specialist

Witt Biomedical Corporation
01.1998 - 01.2003

Registered Nurse

Methodist Hospital
01.1990 - 01.1998

Bachelor of Science - Nursing

Indiana University

Associate of Science - Nursing

Indiana University

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Regina Thomas