Manufacturing responsibilities include scheduling, staffing, oversee a workforce of 50+. Weekly metrics report to leadership team including manufacturing performance, on time delivery, lead time. Manufacturing representative for regulatory audits, material review board, customer complaints, new product development review, document change approval, safety and ergonomics team. Initiate non-conformance reports through closure with corrective actions. Perform root cause analysis and work with engineering on long term solutions for process improvements.

Medical Device manufacturing, aseptic clean room, automation syringe filling process, packaging including sterilization and shipment of product for hospital use.

Managed entire facility operations including Manufacturing, Engineering Design, Customer Service, Purchasing, Supply Chain, Warehouse, Capital Projects, Laboratory Testing, Packaging and Labeling. Reduced material costs and labor by 18%. Increased productivity by 12% by organizing Kaizan events. Established metrics throughout facility and reported results. Developed and trained employees on standard operating procedures for specific jobs including line clearance, safety, hazardous chemicals and waste removal. Responsible for production planning and meeting sales forecast. Generated monthly and quarterly performance reports. Annual budgets and raw material forecasting responsibility.Work with Quality Assurance on achieving ISO-9001 certification.Understand and managed regulatory compliance requirements: QSR, GMP, GLP, MDD and OSHA.Safety Officer and Emergency Response Team Leader responsible for training and documentation. Performed root cause analysis, CAPA implementation and verification. Developed Supply Chain planning schedule to eliminate material shortages.Process validation planning, implementation and completion reports. Led a cross functional team to ensure achieving facility goals.

Managed entire manufacturing operations of 220 people with accountability for meeting productivity goals, on time delivery, lowering cost, and reducing scrap. Project Manager for high tech electronic medical devices, fabrication of custom product. Oversaw a cross-functional operations team, which included production scheduling, purchasing, quality, shipping, receiving and engineering support. Managed a number of projects related to process improvement, electronic design modification, setting up electro-mechanical assembly department, UL submission and approval for new medical equipment. New product design and hand off to manufacturing. Improved line clearance and equipment changeover while eliminating mix-ups. Responsible for a cost reduction project, reducing material costs, and labor savings 20%.Lean manufacturing team leader on multiple product lines, organizing Kaizan events.Lead Auditor for internal audits in accordance with ISO-13485 requirements.Active participant on Engineering support, and New Product Development teams.Provided product specific technical training and support for the Sales and Marketing department.Documented monthly field failure analysis reports to CAPA and bi-yearly to the executive team.Final approval for all manufacturing, inspection, and engineering documentation changes.Documented and maintained process improvement, Kaizan events, including a 5S program.Optimize building layout to reduce waste in travel and increase operational efficiency.Building and production equipment sanitation and line clearance to avoid contamination and mix up.Schedule training program for assembly operations including safety, GMP’s, and soldering.Safety committee and first response leader in accordance to OSHA standards.

Managed clean room class 10,000 high speed assembly operations which increased in capacity by 50% in less than 2 years. Promoted from Quality Department Supervisor to Operations Supervisor after exhibiting fast learning, take charge attitude and responsibility. Focused on lowering costs while improving quality by process changes. Responsible for Manufacturing and Quality Control department, totaling 55 employees.Reduced labor costs by 15% by utilizing lean concepts and design automation.Active participant on achieving ISO-9001 certification process.Trained employees in GMP’s and proper clean room etiquette. Performed validations on new component designs, automated high speed form, fill, and seal equipment. Performed in-house audits and certified suppliers for raw components.Responsible for the incoming inspection and testing of all raw components.Documented all work procedures maintaining compliance and accurate records.Oversaw the Corrective Action Board and issued both internal and external corrective action requests.Maintained regular sanitation and maintenance programs in accordance with regulatory requirements.

Oversaw the Quality Control department for manufactured electronic guidance systems.Wrote work instructions, inspection procedures, test instructions, reviewed test results for Manufacturing and Quality Control Inspection of fabricated metal chassis/electronic devices.Responsible for documenting high cost items to be scrapped and kept in a secure location.Monitored yields and presented process control charts for weekly Director’s meeting.Responsible for acceptance of product in accordance with Military requirements.

Supervised the Quality Control test lab in accordance with Military requirements.Performed Reliability testing and Failure analysis on product.Documented all Quality Control Inspection procedures and changes. Quality Assurance representative for all new product designs with the Customer prior to release.Generated all documentation as required per contract to Military representative prior to shipment.Issued all internal and supplier Corrective Action Notices.