William Drummond
Biocompatibility, Quality Engineering, & Regulatory Management
- Role
- Senior Biocompatibility Scientist at Abbott
- Location
- Pensacola, FL, US
- LinkedIn followers
- 500 followers
About William Drummond
Reliable and honest professional with a strong work ethic and over 20 years of experience managing diverse projects in Biocompatibility, Design and Quality Engineering, Regulatory, and New Product Development. Committed to excellent written and verbal communication. Experienced in leading cross-functional team projects across corporate sites within the United States, Europe, Asia, and Latin America for new product development, the validation of products and processes, implementation of test procedures, and risk management from the inception stage through commercial roll-out. Proven leader focused on establishing creative solutions through research and statistical analysis. Expert in six sigma projects and tools for cGMP and cGLP within an ISO ISO 13485 medical device, ISO 14971 risk management, and ISO 10993 Biocompatibility regulatory environment with extensive experience in Design Control. Certified lead auditor for ISO 9001, 13485 by Exemplar Global (Certificate Number 118662). Subject matter expert in Biomaterials and Biocompatibility test protocols for Class I, II, Holds an MBA from the University of West Florida (AACSB International Accreditation) with a Graduate Portfolio in Industrial Machinery and a Bachelor of Science from the University of South Alabama with degrees in Biology and Chemistry. Expertise in engineering polymers, biomaterials, metals, ceramics, medical devices, biotechnology, and pharmaceutical development.
Experience
Senior Biocompatibility Scientist
Jul 2022 — Present · Pensacola, FL, US
Responsible for all Biocompatibility Impact Assessments for Abbott Cardiovascular. Risk assessments include identifying any gaps for manufacturing sites, process, process aids, packaging, and material changes. Provide guidance to meet FDA, BSI, or EU MDR submissions. Deliverables are process and material equivalence tables, verification and validation activities to ensure no particulates, device morphology, MSDS, REACH Certificates, FTIR analysis to compare bulk material changes, Chemical…
Education
University of West Florida
MBA, Industrial Machinery Industry
University of South Alabama
BSc, Biology and Chemistry
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