Kathryn Cramer Email & Phone Number

Warren, Nj

Ortho Clinical Diagnostics, Raritan, Nj

- Championed quality and improvement projects to support global manufacturing and supply base. Managed over 1,000 direct materials.- Led risk assessment teams to evaluate supplier initiated and internal change projects. Managed change control projects in compliance with internal and external guidelines and regulations. Represented organization during FDA and Quality audits.- Performed gap analyses, defined specification limits, and updated product and material specifications.-… Show more - Championed quality and improvement projects to support global manufacturing and supply base. Managed over 1,000 direct materials.- Led risk assessment teams to evaluate supplier initiated and internal change projects. Managed change control projects in compliance with internal and external guidelines and regulations. Represented organization during FDA and Quality audits.- Performed gap analyses, defined specification limits, and updated product and material specifications.- Applied Process Excellence and Six Sigma methodology in order to drive root cause investigations and supplier certifications.- Led cross-functional teams to execute qualification, validation, and technical transfer activities in support of key initiatives. Show less

Skillman, New Jersey

• Led the Process R&D organization in the development of innovative medical devices, manufacturing processes and equipment.• Direct manager of Process Development technicians and engineers, and Precision Fabrication & Tooling supervisors and machinists, as well as extensive clinical production and laboratory facilities.• Developed and delivered solutions for proof of performance, pouch manufacturing equipment, and design for manufacturing projects.• Represented Process R&D in… Show more • Led the Process R&D organization in the development of innovative medical devices, manufacturing processes and equipment.• Direct manager of Process Development technicians and engineers, and Precision Fabrication & Tooling supervisors and machinists, as well as extensive clinical production and laboratory facilities.• Developed and delivered solutions for proof of performance, pouch manufacturing equipment, and design for manufacturing projects.• Represented Process R&D in FDA/CFR/ISO/Quality audits, resulting in continued ISO13485 and CMDCAS certifications.• Delivered product development, process development and R&D-related GMP laboratory and GMP warehousing solutions and services to a wide variety of customers.• Managed the departmental budget, to ensure efficient and appropriate spending toward key projects. Show less

Skillman, New Jersey

• Identified customer needs for new and innovative products. Developed design input and output specifications. Directed design validation, verification, risk assessment, technology transfer, and manufacturing support activities.• Led diverse, cross-functional teams to fulfill pilot trial and manufacturing requests, and device master record builds.• Streamlined internal procedures, improved sample build processes, and increased customer satisfaction.• Ensured compliance and adherence… Show more • Identified customer needs for new and innovative products. Developed design input and output specifications. Directed design validation, verification, risk assessment, technology transfer, and manufacturing support activities.• Led diverse, cross-functional teams to fulfill pilot trial and manufacturing requests, and device master record builds.• Streamlined internal procedures, improved sample build processes, and increased customer satisfaction.• Ensured compliance and adherence to regulatory and corporate requirements. Show less

Skillman, New Jersey

• Coordinated clinical and research sample production, testing, and documentation between laboratories, manufacturing plants, and external vendors.• Transferred test methods to manufacturing plant. Provided validation support to quality engineering. Trained lab technicians, interns, and manufacturing employees on test methods and equipment.

Skillman, New Jersey

• Designed, developed, and documented test methods using new and existing laboratory equipment. Performed IQ/OQ/PQ on critical equipment.• Represented R&D Lab on cross-functional project teams. Participated in the product development process. Evaluated materials and product performance through extensive testing. Summarized and communicated data and results.

Skillman, New Jersey

Post-Graduate Intern (2003); Co-op/Intern (2002)• Conducted research on an innovative medical device. Consulted vendors and evaluated materials through extensive laboratory testing. Fulfilled integral role in transforming an innovative design into marketable product. Interacted closely with R&D, marketing, and manufacturing.