Robert Scheel
Quality Manager Fca and Stop Shipment @Olympus Corporation
Signup · Get unlimited contacts
WORK HISTORY
Quality Manager Fca and Stop Shipment @Olympus Corporation
In my role at Olympus EMEA, I lead the implementation of Field Corrective Actions (FCA) across the EMEA region, working closely with cross-functional teams including Finance, Legal, Compliance, and Product Management. I coordinate the distribution of Field Safety Notices (FSNs) to ensure product safety and regulatory compliance.Key Responsibilities:Overseeing the execution of FCA processes in EMEA, from planning to implementation.Collaborating with various departments to ensure alignment and approvals.Managing shipping holds to prevent the distribution of non-compliant products.Communicating with regulatory authorities and prepare FCA reports (Initial, Follow-up, Final)Ensuring the accuracy of consignee lists and managing post-market surveillance data.I leverage tools like Marketpoint, Excel and SAP to track progress, manage reconciliations, and ensure compliance across all regions.
EDUCATION
Technische Hochschule Lübeck
Bachelor of Applied Science - BASc, Biomedical/Medical Engineering
ABOUT ROBERT SCHEEL
Quality Manager | Field Corrective Actions (FCA) & Post-Market Surveillance | Regulatory Compliance & Patient Safety in EMEAAs an experienced Quality Manager in the medical device industry, I ensure regulatory compliance and patient safety by driving effective Field Corrective Actions (FCAs) and post-market surveillance across the EMEA region.I have successfully led the implementation of complex FCA campaigns, issuing Field Safety Notices (FSNs) and coordinating execution with subsidiaries, distributors, and regulatory authorities. My work includes managing shipping holds to prevent distribution of non-compliant products, ensuring timely resolution in close collaboration with logistics and cross-functional teams.With hands-on expertise in EU MDR, ISO 13485, CAPA, vigilance, and complaint handling, I bring a strong track record of aligning Finance, Legal, Product Management, and Field Service Engineers to deliver compliant and efficient outcomes. I leverage tools such as Marketpoint, SAP, Power BI, and data management systems to drive transparency, monitor reconciliation rates, and support data-driven decision making.Key areas of expertise:• Field Corrective Actions (FCA) & FSN implementation• Post-Market Surveillance & regulatory reporting (Swissmedic, HPRA, BfArM, IGJ, etc.)• Shipping hold management & logistics coordination• Cross-functional stakeholder alignment & project leadership• Data analytics & compliance tracking (Marketpoint, SAP, Power BI)I am passionate about advancing quality and regulatory excellence in the medical device sector and open to connecting with professionals and organizations committed to strengthening patient safety across global markets.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.