ANA M. CASTAÑEDA
San Antonio,TX
Summary
Regulatory compliance engineer with extensive experience in driving regulatory improvements at Lancer Worldwide. Proven ability to streamline processes and enhance collaboration across departments, ensuring project success. Strong communication and teamwork skills facilitate effective partnerships to achieve product compliance and quality standards.
Overview
12
12
years of professional experience
Work History
Regulatory Compliance Engineer
Lancer Worldwide
San Antonio, TX
01.2021 - Current
- Manage and monitor domestic and regulatory compliance for all product platforms and components.
- Collaborate internally and with third-party agencies to conduct audits and certification assessments for regulatory compliance with applicable standards.
- Conduct internal regulatory audits and follow up on corrective actions to align with regulatory standards.
- Collaborate with Engineering department to release new products that meet regulatory compliance requirements.
- Review product documentation (manuals, instruction sheets, and spec sheets) and work with Technical Writer to create or update documentation to meet regulatory compliance requirements.
- Create critical components lists for agency that includes putting together descriptions and component illustrations to provide better understanding of product.
Documentation and Configuration Supervisor
FBD Partnership, LP
San Antonio, TX
11.2018 - 11.2020
- Managed and organized Document Control group workloads to complete objectives and provide supporting documentation related to the release and commercialization of new products.
- Developed, implemented, and maintained internal processes for the Engineering department and trained personnel on the processes.
- Worked with Engineers to ensure all drawings and Engineering Change Orders were compliant with Manufacturing and Quality requirements.
- Worked with Technical Writer to create needed documents for product releases or product changes including manuals, instruction sheets, spec sheets, product training materials, and service bulletins.
- Coordinated with the Project Management team to make sure all required documentation, parts, and Bills of Materials were released to meet project deadlines.
- Collaborated cross-functionally to implement Engineering Change Orders.
- Presented metrics to Engineering Management on Engineer performance related to Engineering Change Orders (i.e. number of days request is open, total number of pending requests by engineer, processing times).
- Served on the ERP Core Team to identify and map Design-to-Build requirements for new system implementation.
- Reduced the number of Engineering Change Requests processed by the Engineering Department from about 1,000 to about 200 per year over a period of one year by streamlining the change request and change order processes.
- Reduced the number of Deviations processed by the Engineering Department from about 1,000 to about 50 over a period of three years by updating the Deviation process requirements without affecting the quality of the product.
- Created spreadsheets with macros to provide real-time data allowing Engineering Managers to identify pending Engineering Change Orders with longstanding timelines and to identify total number of pending items per Engineer.
- Reduced the amount of updates required for Bills of Materials by reformatting the BOM structure with fewer levels.
- Restructured Document Control employees’ responsibilities allowing Engineers/Designers to work more efficiently on project activities.
- Created smart part number formats to use on documentation, allowing departments to better identify model specific documentation.
- Collaborated with Marketing team to update the format of various documents required for commercialization of units to allow customers to have a better understanding and use of the product.
Project Engineer
FBD Partnership, LP
San Antonio, TX
08.2017 - 11.2020
- Collaborated with Sales & Marketing teams to finalize new unit configurations, release kits, and documentation for customer-specific requests, enhancing support for local and international clients.
- Coordinated with Technical Writer to develop documentation tailored to meet specific customer needs, improving clarity and usability.
- Trained and supported Configuration Engineer on agency compliance processes, ensuring adherence to regulatory standards.
Configuration Engineer
FBD Partnership, LP
San Antonio, TX
12.2013 - 08.2017
- Maintained agency certification for products to meet NSF, UL, CSA, IEC, EN, and SAA requirements.
- Provided agency regulatory guidance to Engineers during new product development.
- Worked with Supply Chain, Manufacturing and QA to implement agency compliant components.
- Performed internal audits to prepare for agency audits.
- Developed procedures for Engineering documentation processes.
- Reviewed changes to processes and documentation.
- Configured and maintained Bill of Materials for all manufactured assemblies within the ERP system.
- Completed various component and unit agency certifications for the U.S. and international markets, including updated testing for standard updates.
- Identified components needing updates for agency compliance, collaborating with Purchasing, Quality, and agency to test and approve materials for sanitation and safety requirements.
- Collaborated with Designers to update 200+ drawings for agency-related components, incorporating specific compliance requirements to enable Quality to identify compliant components.
- Centralized ownership of standards within the company, improving tracking mechanisms and reducing duplicate purchases.
- Took on Document Control responsibilities for several months while the group was shorthanded.
Education
Bachelor of Science - Mechanical Engineering
University of Texas at San Antonio
San Antonio05-2012
Skills
- Regulatory compliance
- Document control
- Project management
- Problem solving
- Verbal communication
- Written communication
- Teamwork
- Operational improvement
- Organizational skills
- Prioritizing skills
- Attention to detail
Leadership Experience
- Alamo Regional Academy of Science & Engineering, San Antonio, TX, Special Awards Chairperson / Logistics Director, 09/1998, 05/2010, Contacted local and regional organizations and universities requesting special awards (i.e. scholarships or other prizes) for participating students., Coordinated with local professionals to participate as science fair judges., Prepared logistics of fair and assisted fair directors with planning, set-up, and running of science fair events., Submitted reports on winners and resolved any issues with awards., Participated in coordinating other events for the organization such as seminars and workshops for students, parents and teachers.
- ExxonMobil Texas Science & Engineering Fair, San Antonio, TX, Special Awards Chairperson, 01/2005, 05/2009, Carried out duties at a statewide level concurrent with the Alamo Regional Academy of Science & Engineering., Prepared logistics for over 1,000 exhibits at the Engineering fair (including table and electrical requirements)., Coordinated with convention center and other staff to ensure requirements were met and provided support to other areas as needed., Inspected and verified student exhibits adhered to regulations prior to judging day., Prepared reports on student participation, winners, and award acceptances.
Timeline
Regulatory Compliance Engineer
Lancer Worldwide
01.2021 - Current
Documentation and Configuration Supervisor
FBD Partnership, LP
11.2018 - 11.2020
Project Engineer
FBD Partnership, LP
08.2017 - 11.2020
Configuration Engineer
FBD Partnership, LP
12.2013 - 08.2017
Bachelor of Science - Mechanical Engineering
University of Texas at San Antonio