Dillon Plummer, Ms Email & Phone Number

California, United States

• Promoting efficiency in supplier onboarding, evaluation, management, and continuous monitoring
• Maintaining compliance with international standards for medical device safety, including ISO 13485, ISO 14971, and EU MDR requirements, and the FDA Office of Regulatory Affairs
• Supporting research and development (R&D) engineers in achieving the high-quality vendor data that is necessary to meet strict FDA regulations as their specification input
• Leading the Material Review Board to… Show more
• Leading the Material Review Board to disposition nonconforming components and performance from suppliers, as well as drafting and signing the final dispositions
• Owning the evaluation, return, followup, and resolution of supplier corrective action requests (SCARs), and presenting quarterly to executive leadership

San Francisco Bay Area

• Maintain compliance with ISO 13485 and EU MDR requirements
• Tactically meet company and department objectives, and maintain timely review and release of product
• Develop, implement, and maintain GDP and GMP in the Manufacturing and Operations Departments, including batch records, engineering specifications, current BOM, and labels.
• Lead the Material Review Board to disposition nonconforming components, as well as drafting and signing the final material disposition
• Manage the… Show more
• Manage the evaluation, return, followup, and resolution of nonconforming material reports (NCMRs) and supplier corrective action reports (SCARs)

San Francisco Bay Area

• Maintain compliance with regulations and standards (GDP, GMP, GxP) and work closely with the Quality Assurance team to create NCMRs and SCARs, and to assist with CAPAs as needed. Strong emphasis on ISO 9001 and ISO 13485
• Develop and oversee the company's inventory management and ERP systems with an emphasis on timely reconciliation
• Forecast and analyze demand/supply status to support the Manufacturing Operations, R&D, and Engineering departments with material needs
• Source… Show more
• Source, grade, audit, and onboard partner contract manufacturers, in close collaboration with QA
• Create and maintain supplier scorecards and vendor assessments, with an emphasis on resolving shipping related issues

San Francisco Bay Area

• Read and interpret engineering drawings and architectural plans
• Maintain knowledge of state and federal building, plumbing, electrical, mechanical, fire, and health codes, and federal ADA regulations
• Verify that each job has the appropriate permits and signatures, and solidify project timeline
• Lead design review meetings with the municipality, architects, structural and electrical engineers, and clients
• Prepare for and attend all field inspections on assigned projects
• … Show more

San Francisco Bay Area

• Review contracts and subcontracts to determine scope of work and permitting needs
• Own the entire permit lifecycle for all projects
• Draft and submit applications for appropriate permits from the municipality
• Assist the Project Managers throughout the permitting and inspection process, including design review meetings with the municipality, architects, and structural engineers
• Schedule field inspections
• Maintain knowledge of state and federal building codes

Phd, Artificial Intelligence (Focus: Medical Devices)

Research focus: AI implementation in medical device risk management

Ms, Statistical Research Methodology

Ba, Liberal Arts