Juan Carlos De La Cruz

Key Responsibilities

• Process Control & Monitoring: Ensures all process conditions (pressures, temperatures, cycle times) are monitored and controlled according to validated specifications to ensure product consistency and minimize risk to the end-user.
• QMS Leadership: Ensures a sound Quality Management System is implemented, maintained, and audited. Serves as the primary lead for ISO 13485 certification and regulatory inspections.
• Change Management: Strictly enforces that all product and process changes follow the MSA/CSA process sequence, ensuring no unauthorized deviations impact the device's safety or regulatory filing.
• Lab & Testing Oversight: Ensures all testing adheres to the Avient Lab Performance Policy. Oversees timely product grading, ensuring that all measurement equipment is calibrated and results are documented per medical-grade standards.
• Professional Representation: Represents the plant and Avient in professional dealings with medical customers, the technology community, and commercial groups. Acts as the technical subject matter expert for quality inquiries.
• Complaint & CAPA Coordination: Leads the investigation and Corrective/Preventive Action (CAPA) for all plant-related customer complaints, focusing on root cause analysis to prevent recurrence.
• Training & Competency: Assesses training needs and provides specialized training to production employees, specifically regarding Good Manufacturing Practices (GMP) and ISO-specific documentation. Standardized site-wide compliance by designing a multi-modal ISO 13485 training curriculum. By integrating this program into the New Employee Orientation (NEO), I established a sustainable 'Quality First' culture, ensuring all personnel possess a rigorous understanding of medical device manufacturing expectations and audit readiness.
• Continuous Improvement: Manages various audits (Safety, ISO 9001, ISO 13485) and executes other projects as assigned to maintain a culture of high quality and safety. Institutionalized compliance reviews to identify critical gaps and establish a robust framework for continuous monitoring. By leveraging targeted CAPAs and cross-functional training, we validated our core methodologies, providing NEU leadership with full confidence in our operational integrity. Leads cross-functional Kaizen events to eliminate waste and optimize manufacturing flow while maintaining strict adherence to ISO 13485 standards. Ensures that all process improvements are properly validated and documented within the change control system.

• Extruder Operator, Blending, Packaging.
• Perform quality checks on the line for high quality product.
• Ensure proper labeling, verify order number is correct (raw materials, order number in the system) all ingredients are visible, visually inspect for foreign materials, pellet count.
• Weighs ingredients to meet recipe specification.
• Checking all controls for adherence to mixing, packaging, extrusion procedures.
• Monitor production (extruder temperature, water temperature, color, voids, dusting)
• Monitor equipment to ensure safe and efficient operation.
• Ensure to wear proper PPE for personal safety and quality.
• Conduct efficient basic line / job change-overs.
• Complete final paperwork and ensure content is accurate per standard operating procedures.
• Report any downtime and maintenance done during every run.
• Assist others operator with machine set-up and operations.

• The Process Assistant is assigned to the area manager, and will hold responsibilities specific to the different fulfillment center areas.
• Key job elements: Support and work in the department as required, helping support daily management of department duties, allocating labor, leading meetings, assigning job duties, and communicating with internal and external suppliers, providing vacation coverage for area managers.
• Follow-up attendance tracking.
• Training associates.
• Ensuring successful area performance.
• Reporting workflow of every area to the manager.
• Filling in as needed with production duties.
• Understand workflow and daily production goals.
• Coaching associates to work safely at all times.
• Referring all job injuries immediately to area manager.
• Inbound Operation: includes leading associates to their designated areas to unload trucks on a successful timely manner, safely and carefully to provide customer satisfaction.
• Led the problem Solve area.

• Machine Operator / Backup Supervisor for the packaging department.
• Supervise first shift operations by working with staff to create an open and positive working environment.
• Full Knowledge of machine assembly, adjustments, troubleshooting of every piece of equipment on the packaging department area (Feeder stations, Slicer Machines, Wrapper Machines, Baggers, Quick-Lock Machines, Packing Robotic Cells, Stacking Machines).
• Contribute to QA Lab and Management with final paperwork collected at the end of the shift.
• Assist daily production meetings.
• Report any irregularity during the production process for each product run.
• Collect quality Information every 15 minutes at every operation station (Number of slices, Temperature, Height, Width, Color, Wrapping, Bagging, Dates etc.)
• Ensure metal detectors were properly calibrated and had all wands for properly setup at begging of each run.
• Ensure every scale was properly calibrated and had the correct speed before each run.
• Ensure operators had proper paperwork, specific supplies and necessary tools for each variety to perform their duties.
• Ensure paperwork, tools, parts, equipment and supplies were properly labeled, clean and store in the work area. Practicing 5S culture to maintain customers, employees and plant safe from accidents and foreign materials.
• Schedule with maintenance for repairs and improvements.
• Verbally communicate directly with supervisor of other departments, management, maintenance. On emergency breakdowns inform manager of any related downtime.
• Support and encourage continuous improvement of the company processes, including safety programs and quality.
• Certify on TWI (Training Within Industries)
• Developed all training manuals for all machines on every department of Pepperidge Farm Bloomfield.
• Part of the training team for Cornerstone (Data collection software which eventually removed paperwork done manually at specific stations).

• Sargent E5 Infantry 11B.
• Veteran.
• Ordered to active duty in response to the World Trade Center and Pentagon attacks.
• Active duty in support of Operation Noble Eagle.
• Army achievement medal.
• National defense service medal.
• Armed forces reserve medal w / "M" device.
• Army service ribbon.
• Honorable Discharge.