Production Supervisor
Resume:
Rachel Cuellar PO Box ***
Lake Jackson, TX *****
ad5dx0@r.postjobfree.com
Bilingual (Spanish) Production Manager with 35+ years of experience in medical device assembly and production management.
Experience
Millar, LLC June 2023 – March 2024
Production Supervisor
• Manage 40+ employees.
• Responsible for all personnel and production issues / activities and reports to Manager in a timely manner.
• Maintaining good manufacturing practices and a good quality product is built.
• Ensure all production and quality rules are met within the company.
• Assists with any NCMR’s created and follows process through to the end along with any scrap or rework needed to complete the task.
• Responsible for contacting appropriate personnel outside of the department for any issues that may arise (ex. Engineering, Maintenance, Facilities, Cal. Etc.)
• Effectively communicate production issues with Manager and engineering for resolution of quality and yield issues.
• Verify workorders for accuracy and correct lot numbers before closing workorder.
• Participate and Assist with Audits
• Direct and coordinate daily activities of employees for assembling, inspecting, testing and rework assemblies if needed along with finished products.
AJ Medical Manufacturing May 2020 – June 2023
Operations Manager
• Train new employees in all aspects of the product assembly (as well as in Spanish as needed)
• Manage 10+ employees.
• Responsible for all personnel and production issues / activities and reports to President in a timely manner.
• Responsible for maintaining production schedules and ensuring goals are met daily.
• Maintaining good manufacturing practices and a good quality product is built.
• Ensure all production and quality rules are met within the company.
• Responsible for maintaining training records and ensuring they are up to date per employee.
• Initiates and assists with any NCMR’s created and follows process through to the end along with any scrap or rework needed to complete the task.
• Responsible for identifying personnel for promotions, performance evaluation, training, and discipline of each production employee throughout the department.
• Responsible for contacting appropriate personnel outside of the department for any issues that may arise (ex. Engineering, Maintenance, Facilities, Cal. Etc.)
• Effectively communicate production issues with engineering for resolution of quality and yield issues.
• Work directly with Engineering to onboard new products prior to releasing to production.
• Redlined documents for ease of manufacturability and corrections as necessary.
• Receiving – verified all parts received against PO’s and audited the incoming documentation against purchasing requirements.
• Logistics – Perform all shipping of goods domestic and international and complete commercial invoices, packing lists, certificate of origin, etc.
• Create and issue workorders to Production in CETEC system.
• Verify workorders for accuracy and correct lot numbers before closing workorder.
• Create PO’s and contact vendors as needed.
• Assist Quality Management with documentation, DECN’s and CAPA’s
• Participate and Assist with Audits
• Applied all invoices to ledger and communicated with CFO and Accounting Department to ensure payments are made in a timely manner.
• Direct and coordinate daily activities of employees for assembling, inspecting, testing and rework assemblies if needed along with finished products.
• Assists with Planning for Production Scheduling
• Keep track of all NDA’s and confidential information pertaining to the customer / client.
• Oversee production hourly times are correct, submitted and electronically sent to AP along with upkeeping of attendance.
• Production quality controls, assessing material and build issues for reconciliation with non-conforming materials process.
ReliantHeart Inc. / Micromed Technology June 2001 – May 2020 Production Manager / Supervisor
• Trained new employees in all aspects of the product assembly.
• Managed 20+ employees (assemblers, test operators and machinist)
• Responsible for all personnel and production issues / activities and report to Upper Management in a timely manner.
• Effectively communicate production issues with engineering for resolution of quality and yield issues
• Production quality controls, assessing material and build issues for reconciliation with non-conforming materials process.
• Electronic document control for training, procedures, drawings, work-orders, complaints, and CAPA
• Root cause analysis on returned products and customer complaints.
• Operated complaint investigation team and interfaced with Engineering.
• Operated the CAPA system – Investigation through effectiveness verification.
• Assisted in using MRP to determine purchasing of all components making up implantable LVAD device which included negotiating price and lead time for over 350 components.
• Managed RGA and RMA materials and help either return to stock or disposition for future use.
• Receiving – verified all parts received against PO’s and audited the incoming documentation against purchasing requirements.
• Logistics – Perform all shipping of goods domestic and international and complete commercial invoices, packing lists, certificate of origin, etc.
• Assists with Planning for Production Scheduling.
• Assist in recruiting and identifying personnel through interdepartmental transfers, promotion, performance evaluation, training, and discipline of each production employee.
• Yearly performance reviews and any disciplinary actions that may arise.
• Ensure all production and quality rules are met within the company.
• Responsible for contacting appropriate personnel outside of the department for any issues that may arise (ex. Engineering, Maintenance, Facilities, Cal. Etc.)
• Interviewed new employee prospects and created a test evaluation for soldering to test candidates for soldering capabilities.
K-TEC Electronics August 2000 – June 2001
3rd Shift Line Lead
• Oversaw 30+ employees.
• Trained employees to assemble and test printed circuit boards: soldering, flash controller.
• Established workstations with job specific tooling and equipment.
• Consistently met production goals
Intermedics June 1984 – December 1999
Senior Line Lead
• Oversaw 30+ employees.
• Trained employees in the assembly of PCB, computer systems, and electronics
• Eliminated idle time by coordination with planning.
• Consistently met production goals
• Complete inventory management and reconciliation
• Material handling, line clearance, and lot control Skills
Production Manager Class 3 and 8 Medical Device ISO13485 Quality System Implantable Device Production Electronics Assembly
PCB Assembly & Test Production microcontroller Clean room management Bilingual English-Spanish flashing & program verification and recertification CAPA Complaints Returned Goods
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