Jeff Keith Email & Phone Number

Spencer, IN, US

Marlborough, MA, US

Quality management responsibility for Endoscopy products.

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

Marlborough, MA, US

• Quality Lead for a new product platform within the Endoscopy business for 163 finished good codes (Advanix™ Pancreatic)
• New Product Quality Engineer for a new product platform within the Endoscopy business for 1 finished good code (Spyglass™ DS®)
• Provided leadership, technical and administrative direction, coaching, and/or mentoring to lower level employees and consultants in definition, implementation, and verification of processes, work products, and an.
• Supervise and lead team of 3Engineers and 4 Technicians
• Support and practice Best In Class Quality Engineering practices
• Implementation of Quality Assurance Plans, Process Controls, CAPA initiatives, In-Process Test Methods, OQ/PQ Testing methods, Product Specification test methods

Marlborough, MA, US

• Support PDP / NPD deliverables on Endoscopy platform for 87 finished good codes of Advanix Biliary™ Stent and NaviFlex™ RX Delivery System.
• Support and practice Extended Core Team deliverables.
• Implementation of Validation Plans, Protocols, Incoming testing methods, In-Process testing methods, and Process Validation methods.
• Received CAPA award for Tyvek™ pouch Corporate TMV remediation driven from an NCEP escalation
• Maintained a stronger understanding and knowledge with the following…o Test Method Validationo Process Validationo Equipment Qualification o Risk Analysiso First Articleso Incoming Q.A./RBIA.
• Ensured and instilled BSC regulatory, FDA and ISO compliance in all areas of responsibilities.

Marlborough, MA, US

• Support PDP / NPD deliverables.o 87 finished good codes of Advanix Biliary™ Stent and NaviFlex™ RX Delivery System.o 4 finished good codes of EndoVive™ 2-Port and 3-Port TTP J-Tubeso 1 finished good code of DreamWire™.
• Support and practice Best In Class Quality Engineering practices
• Implementation of Quality Assurance Plans, Process Controls, and CAPA initiatives
• Have a strong understanding and knowledge with the following…o Test Method Validationo Process Validationo Equipment Qualification o Risk Analysiso First Articleso Incoming Q.A./RBIA.
• Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.

Marlborough, MA, US

• Performed field and lab calibrations in accordance to procedures and Mil-Specs on physical dimension equipment, temperature gaging, other various T&ME.
• O.T.R., NCR, and NCEP processing
• Calibration Lead during Project Horizon / P.V.R. (process input review lead to first time calibration execution within BSC Spencer)
• Control and update calibration databases,CCMS, PRIMO
• Maintain and manage calibration metrics
• Have worked with a variety of methods, standards, equipment, and instrumentation

Marlborough, MA, US

• Run Moisture analysis, Titration, and Viscosity testing.
• Preventative maintenance on equipment.
• Maintained coatings inventory (Primer, MEK, Topcoat, and Neutralizer)
• Updated databases internally to monitor production.
• SAP operator for issuing coating utilized
• Developed coating technician lab log that enabled core team to observe weekly data that was necessary to everyday production.

Bachelor'S Degree, Business Administration, Management And Operations

Associate'S Degree, Business Administration, Management And Operations

Certificate, Six Sigma Green Belt