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.

• 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

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

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