Donald Windland Email and Phone Number

- Serve as the Quality point of contact and lead for the digital health product development teams in medical device design control, from proof of concept through Launch.- Guide and influence internal Lilly technology teams, alliance partners, and Contract Manufacturers on the applicable Quality Management System (QMS) to be followed- Provide Quality oversight to review the regulatory requirements for design control and European Union – MDR, e.g., General Safety and Performance… Show more - Serve as the Quality point of contact and lead for the digital health product development teams in medical device design control, from proof of concept through Launch.- Guide and influence internal Lilly technology teams, alliance partners, and Contract Manufacturers on the applicable Quality Management System (QMS) to be followed- Provide Quality oversight to review the regulatory requirements for design control and European Union – MDR, e.g., General Safety and Performance Requirements (GSPR), CER and PMCF plan etc.- Provide inputs into the preparation and review of technical documentation to ensure EU MDR requirements are met to facilitate Notified Body (NB) review and approval. Participate in NB inspections for the applicable device products and coordinating where needed with Lilly Affiliates, EU regulatory and labeling groups, EU Global Product Safety (GPS) etc as necessary to support product pre and post launch- Quality representative to support clinical trial lot release process- Review/approve documents including protocols, technical reports, deviations, change controls, inspection procedures, specifications, drawings, sampling plans, and validation packages.- Participate and provide input on Risk Management Activities including Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and/or Safety Assurance Cases- Lead and participate in ongoing continuous improvement projects- Assist teams with internal and supplier audits (including due diligence) and maintain supplier development partnerships.- Work collaboratively with Lilly's Regulatory team to assure compliance with applicable registrations, standards, guidance documents, and requirements.- Support applicable Quality System activities (periodic reviews, self-assessments, CAPA, Development Quality Agreements, etc.) as needed. Show less

Validation Lead and Test Execution Lead

Quality Auditor (External), December 2010 – December 2011Quality Compliance Associate, May 2010 – November 2010Quality Auditor, November 2007 – April 2010