Jay Davis Email & Phone Number

Trained and developed personnel in Quality and Regulatory roles, fostering a culture of continuous learning and compliance.Coordinated training programs for all company personnel, ensuring company-wide adherence to quality standards.Manage engineering projects through validation, ensuring alignment with regulatory requirements and quality standards.Responsible for the research and selection of processing equipment and tracking of performance to identify opportunities for improvement.Served as a technical resource for regulatory affairs, interpreting and applying 21 CFR regulations to company processes.

Interim Director of QA/RA (Dec 2018 - Present)13485:2016 Certified Lead Auditor (Exemplar Global)• Direct all CAPA activity• Develop Design Transfer Procedures and Work Instructions for all new products• Responsible for the implementation and development of a paperless Quality Management System (QMS)• Responsible for the development of personnel in Quality and Regulatory roles• Coordinate all training development for all personnel• Project Manager for all engineering projects• Provide technical support for Gage R&R’s utilizing Minitab• Management Representative for the company• Responsible for addressing customer complaints

Watford, Hertfordshire, Gb

• Responsible for planning and managing multiple top-priority project launches for orthopedic instruments and implants to meet critical deadlines• Developed capital budgets for equipment, fixtures, gauging, and process improvement ranging up to $2.2M• Leading a team responsible for an international launch and implementing standards at supplier locations• Develop and direct activities of reports to help deliver on objectives and support business needs• Provide regular updates on projects, issues, and mitigation activities to departmental and business leaders• Responsible for review of drawing prints and models for manufacturability and evaluating process capability (GR&R, Control Plans, FMEA, Cpk, IQ, OQ, PQ) to ensure long-term manufacturing stability• Manage the completion of Matrix (PLM - product life management) structure, SAP BOMS, routings, production versions, and master data

Watford, Hertfordshire, Gb

• Responsible for coordinating activities between Product Development, Manufacturing, Quality, Regulatory, Research, and Marketing• Responsible for monthly updates and providing regular presentations and updates to executive leadership

Watford, Hertfordshire, Gb

• Monitored operations and implemented process improvementes• Review of drawing prints and models for manufacturability and conducting process capability studies and performance qualifications• Developed and improved finishing operation efficiency resulting in a throughput increase of 33%• Supported new product launches by reviewing prints for accuracy, manufacturability, and process requirements for respective areas• Developed manufacturing project timelines for launches• Received recognition after developing database to analyze the sources of loss resulting in improved performance

Us

• Lead engineer of design and implementation team on $12.4M assembly-line modification project• Led $1.1M major production line to successful completion, on-time, and within budget• Directed operator-improvement programs which resulted in pass yields rising from 88% to 95%• Created an extensive report database used plant-wide to identify issues relating to departmental trends. Real-time and historical information tracking also allows for drill-down to machine and operator levels.• Installed computer-based refrigerant charging system to improve accuracy and record-keeping. Realized throughput increase of 3%.• Successfully led multiple Kaizen teams to significant line-length and on-line material requirement reductions

• Completed software design project associated with tracking eye movement for laser surgery.• Developed a software routine using LabView to ablate (laser etch) pattern based on required correctionU.S. Patent No. 6,500,171 B1 awarded for this work.

• Directed multiple aspects of system design, purchasing, production scheduling, system-startup scheduling, new product development, quality control, and document control.• Evaluated and approved suppliers based on technical competencies, capability, and cost effectiveness• Created administrative systems to maintain efficient and effective customer service

Lancashire, England, Gb

• Planned, organized and controlled the activities of new product introduction, quality systems integrity, process equipment support and improvement, new equipment approval and installation.• Directly supervised 11 resource personnel and 40 support personnel in quality, electrical, mechanical, and process engineering departments.• Managed reduction in department size by 55% while maintaining quality and efficiency• Developed several programs for improving customer relations through ambassadorships• Coordinated major installation schedules with responsibility for budget development and management.

Lancashire, England, Gb

• Installed, programmed, and trained personnel on use of Fanuc robots and robot vision systems, including development of company’s extensive robot training manual• Oversaw program development for process equipment, which increased production yield from 91% to 96%.• Designed, programmed, implemented, and supported servo drive systems, Man/Machine Interfaces, Allen-Bradley CVIM2 computer vision system, and PLC controlled process equipment.

• Directly supervised maintenance and toolroom supervisors, and maintenance buyer• Managed annual purchasing budget of $1.3 million for maintenance and toolroom• Initiated and executed plant engineering and capital projects for maintenance and tooling departments• Conducted monthly safety meetings and managed backlog reduction of 52%.

• Designed equipment for in-plant use including project cost justification and budgeting.• Provided electrical schematics, panel layouts, mechanical design, and all related documentation for projects.• Developed computer and PLC programs for machine control• Optimize Fanuc and Prab robotic programs• Designed computer-controlled taper measuring device reducing inspection time from 17 minutes to 1 minute

• Implemented computer network for controlling and recording furnace activities• Designed equipment modifications for improving product quality and productivity.• Performed electrical design and layout, programmed robotic operations, and designed cambering forms for production, and calibrating furnace controllers.

Bachelor Of Science, Electronic Engineering Technology

Lean Six-Sigma Black Belt