Daniel Schabacker Email & Phone Number

• R&D Project Manager leading capital and consumable product development projects/workstreams related to medical device - reprocessing and terminal sterilization in order to protect patients during their most critical.
• Leading the creation, implementation, reporting, and communication of project plans.
• Ensuring plans and deliverables are compliant with appropriate ASP design control procedures.
• Leading project teams and identifying and addressing critical path constraints… Show more R&D Project Manager leading capital and consumable product development projects/workstreams related to medical device.
• Leading project teams and identifying and addressing critical path constraints or road blocks
• Developing, maintaining and using tools for organizational tracking such as budgets, resource deployment, project status/reporting, etc.

Greater San Diego Area

• Stratus and Associates is a sole proprietorship. Through client agreement, Stratus is able to function as a project manager, study director, study monitor, or in a regulatory support role to address a full range of.
• R&D and Regulatory Product Development Study Management and Monitoring built on principles of Project Management best practices; Creative Solutions to Test… Show more Stratus and Associates is a sole proprietorship..
• R&D and Regulatory Product Development Study Management and Monitoring built on principles of Project Management best practices; Creative Solutions to Test System Challenges.
• Knowledgable in Design History File preparation, Quality Assurance, and GLP audit and inspection compliance (FDA, EPA, OECD)
• Data compilation, management, reporting; Data interpretation, evaluation, and reporting Areas of expertise:
• Enzyme (Microbial & Bioprocessed) and Agrochemical (Crop & Professional Products)

Irvine, California, United States

• Quality Engineering and Risk Management subject matter expert in the medical device and consumable technical field, exercising considerable latitude in determining technical objectives of assignments and project.
• Review results of area audits to ensure that… Show more Quality Engineering and Risk Management subject matter expert in the medical device and consumable technical field, exercising considerable latitude in.
• Review results of area audits to ensure that corrective and preventive actions are adequate; partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management.
• Support legacy medical device continuous product improvement projects through quality plans, review of design change plans, supplier change requests, design reviews, development of regulatory support documents (e.g..
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs, and customer complaints; support of Product Quality and Risk Management activities during authority on-site inspections;
• Develop and manage the ASP risk management process and work instructions per ISO 14971 that establish and maintains quality system policies, processes, procedures and controls to ensure that the performance and quality.

Santa Ana, California, United States

• Led global ophthalmic medical device development projects according to PMI PMBOK best practices, applicable standards and regulations with emphasis on risk mitigation, global regulations, and guidance. Familiar, for.
• Emphasis of the critical utility of product life-cycle stage gate and design control processes culminating in completion of design history files, functional submission to / approval by authorities, product manufacture.
• Practical management of the process, development and led cross-functional global teams, developed strategic approaches to the projects, driving execution, and intimately developing the regulatory dossier components.

Project Management and Planning responsibilities supporting full breadth of Biotech Enzyme Division located in Raleigh, NC and San Diego, CA. Sector delivers products to the key biotech enzyme market segments: animal feed, biofuels and new output traits in agriculture. Portfolio included 15+ projects in various stages of life-cycle. Further, responsible.

Based in Basel, Switzerland and Greensboro, North Carolina, position involved Project/Portfolio Management and Planning responsibilities of full breadth of sector portfolios with projects in various stages of life-cycle.Portfolio ran the spectrum of Research, Development, Commercial and Life-cycle Management product phases. Responsible for coordinating New.

Responsible for performing environmental fate studies at the laboratory level under Good Laboratory Practice Standards. Included method development and validation.

Reviewed federal and state action items on individual studies, prepared defences to agency questions and followed through with contracting new studies or upgraded work.Conducted on site GLP/GMP inspections, performed GLP/GMP data audits and prepared all necessary reports. Contracted and monitored regulatory studies at various laboratories, reviewed and.

• Responsible for performing Environmental Fate studies at the laboratory level under Good Laboratory Practice Standards. Included method development and validation

Laboratory procedures and testing performed following acquisition of tissue/cells included the isolation and characterization of lipids, leukocytes, proteins and blood factors. Records were maintained involving the correlation, data analysis and graphic representations.

Master Science - Chemistry, Organic Chemistry, Pesticide Worker Exposure

Bachelor In Science, Chemistry, Math, And Geology

Education record