James Bennett
Director, Post Market Quality at Stryker
Based in Irvine, United States
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Seniority
Director
Department
General Business & Management
Location
Irvine
Industry
Medical Equipment Manufacturing
Company size
51K
Contact information
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j•••••••@stryker.com
Phone
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Background
About James Bennett
Passionate medical device Quality leader with an immense drive for continuous improvement and 13+ years extensive experience in people leadership and Quality Management Systems. I have led various team structures of 20+ individuals and possess a deep skillset in leading through change and uncertainty as evidenced throughout my recent work history. Device experience is primarily Class and includes breast implants, dermal fillers, gastric band, IUD (combination device), spinal implants & instruments, intrathecal pain pump/catheter/programmer (AIMD), AFIB treatment, and thrombectomy devices. Expertise: Quality Management Systems, Complaint Handling/Post Market Surveillance, Regulatory Reporting (MDR/MDVR), NC/CAPA, Product Field Action/Recall, Document Control (Change Orders, Training, Quality Manual), Management Review, Risk Management, Supplier Management, External Standard Management, Device Tracking, Audit (FDA, DQS, BSI), 483 resolution.Compliance: 21 CFR Part 803, 806, and 820, CGMP, ISO 13485:2016, EN 14971:2019, MDR (EU) 2017/745, MDSAP.Programs: TrackWise, Grand Avenue Software, Arena, QAD, Salesforce, eSubmitter, Webtrader, LMS, SAP, Microsoft Office.
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