Lucero Castro
Tracy,CA
Summary
Quality Manager with 7+ years of documented quality control success. Develops specific and measurable goals, improvements and standards to continuously and consistently improve quality and reduce and eliminate errors. Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates quality-related SOP training and enforces procedural adherence.
Overview
17
17
years of professional experience
Work History
Quality Manager
Westec Plastics Corporation
04.2017 - Current
- Championed transition of company's QMS from ISO 9001 to ISO 13485:2016
- Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
- Mentored junior staff members in quality management principles, fostering professional growth among team members.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Maintained professional demeanor by staying calm when addressing unhappy or angry customers.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- Conducted thorough audits to ensure adherence to industry standards and regulatory requirements, maintaining compliance consistently.
- Drove process standardization by creating and implementing SOPs, resulting in increased efficiency and reduced deviations.
- Streamlined production processes by identifying areas for improvement and implementing corrective actions.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Improved staffing during busy periods by creating employee schedules and monitoring call-outs.
- Established team priorities, maintained schedules and monitored performance.
- Promoted a proactive approach to risk management within the organization, mitigating potential concerns before they escalated into larger issues.
- Developed and deployed production control plans and created work instructions and procedures.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
- Increased efficiency of the QMS by regularly reviewing procedures and making updates based on changing business needs or industry advancements.
- Excellent communication skills, both verbal and written.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Passionate about learning and committed to continual improvement.
Customer Service
iHealth Labs. LLC
11.2016 - 03.2017
- Managing incoming flow of calls and e-mails from customers requiring Technical Support
- Follow up with open tickets with customers and cross functional departments until getting final resolution
- Initiate RMA process for device replacement or returned goods.
Quality and Customer Service Supervisor
IRP Medical
06.2015 - 07.2016
- Directly supervised and managed two full time customer servicer representatives and seven quality inspectors
- Ensured company policies and procedures were followed per QMS
- Developed and implemented customer service processes and procedures
- Provided all training for successful job performance
- Handled complicated an sensitive customer request and situations
- Worked with cross-functional departments such as operations and engineering to schedule incoming jobs, communicate schedule needs and product flow in order to meet Customer’s satisfaction and Company’s financial goals
- Data collection and developed reports and charts to help management team with decision making, and MRB
- Supported with driving efforts from CSR and Quality to meet financial goals as part of management team
- Plan and Conduct Internal Audits along with the VP of Regulatory Affairs, as well as host Customer and Regulatory Audits
- Document Control activities
- Responsible for the CAPA, RMA and Non Conforming Product processes and activities.
Quality Lead
IRP Medical
10.2012 - 06.2015
- Planned, supervised and oversaw quality control personnel and coordinated activities in conjunction with other departments and their leaders for assure quality
- Mets and exceeded company production methods and standards as determined by ensuring efficiency and smooth operations
- Provided recommendations for capital expenditures as well as for manpower to increase productivity on the quality control area
- Assisted the Quality Management team to maintain awareness and ensure compliance with current international, Federal and State regulations pertaining to GMP/QSR, ISO9001/ISO13485
- Helped establishing and conducting site-wide training related to GMP/QSR, as well as assisted during internal audits
- Updated quality manual and QA procedures, as applicable
- Worked with cross-functional teams to resolve Quality System and product non-conformances by identifying the root cause and the corrective actions and the effectiveness of those actions
- Reviewed and approved incident reports and CAPAs
- Directed quality of product and associated paperwork in all outgoing shipments to customers and review customer orders criteria stablished to maintain requirements
- In charge of all incoming inspections of product received from outside vendors, and determine acceptability of their products
- Selected a core team member to analyze quality control and assure accuracy.
Buyer I
Flextronics Manufacturing
03.2007 - 05.2011
- Reviewed of requisitions and MRP output
- Coordinated activities involved with procurement and its components
- Conferred with vendors to obtain product or service information such as price, availability and delivery schedule and determine the method of procurement
- Maintained procurement records for productsand services, purchases, costs, deliveries and inventories of reports and metrics
- Managed supplier selling costs, deliveries and approved invoices for payments
- Interfaced with suppliers and customers to assure both, delivery on a timely basis and expedited shipments if necessary
- Made strategic buying decisions and executed corporate sourcing programs
- Conducted quarterly supplier reviews and coordinated RTV process.
Education
ISO 13485:2016 Lead Auditor -
BSI Group America
San Jose, CA08.2017
Certification on Business with International business concentration -
Universidad De Guadalajara
Guadalajara, Mexico06.2007
Bachelors of International Business - Business
Universidad of Guadalajara
Guadalajara, Jalisco Mexico12.2006
Skills
- Advanced Excel literacy
- Word and Power Point proficient
- Team player
- Bilingual: English and Spanish
- Internal Auditing
- Employee Development
- Document Management
- Problem-solving abilities
- Sampling Plans
- Scheduling and Coordinating
- Gage R&R Studies
- First-Article Inspection
- Corrective Actions
- SOP Development
Languages
English
Full Professional
Spanish
Native or Bilingual
Timeline
Quality Manager
Westec Plastics Corporation
04.2017 - Current
Customer Service
iHealth Labs. LLC
11.2016 - 03.2017
Quality and Customer Service Supervisor
IRP Medical
06.2015 - 07.2016
Quality Lead
IRP Medical
10.2012 - 06.2015
Buyer I
Flextronics Manufacturing
03.2007 - 05.2011
ISO 13485:2016 Lead Auditor -
BSI Group America
Certification on Business with International business concentration -
Universidad De Guadalajara
Bachelors of International Business - Business
Universidad of Guadalajara