David Meeks Email & Phone Number

Princeton, NJ, US

• Hired to define and establish a new IT Quality department within IT. Based on interviews with over 25 internal IT leaders, define and implement the charter for a new IT Quality organization. Lead team to proactively.
• Manage small team (8 - 15 people) in U.S. and India
• Create and lead Quality and Compliance function for IT organization of 900+ people
• Establish a new governance and expand the IT Quality audit team by 29% in 12 months
• Redefined IT training strategy and improved IT training compliance by 30% in 10 months
• Completed 13 CAPAs to successful, effective closure

Warsaw, Indiana, US

• Associate director for quality systems, including internal quality audits, CAPA review board, and quality system and production software validation. Re-establish quality audit program for company rebounding from.
• Manage small team (8 - 12 people) in U.S. and India
• Quality leadership at the global headquarters for $8 billion worldwide leader in orthopedic implants
• Grow the internal Quality audit team by 67% in 15 months and increase audit activity by 25%
• Streamline quality audit and software validation through introduction of validated workflow tools and electronic signatures
• Direct interface with 4 notified bodies and competent authorities, including FDA, BSi, Ukraine, and Kazakhstan, in quality system audits

Basel, CH

• Senior manager for R&D compliance engineers, blood glucose meter safety and certification engineers, and IT validation experts. Overall software process owner for medical device product software and IT / operations.
• Managed small team (6 - 10 people) in U.S., Europe, and India
• Led the compliant transition of 500+ Bayer Diabetes Care business applications to 70 replacement solutions for Ascensia Diabetes Care in 21 months from January 2016 to October 2017
• Reduced business IT license and operational costs by over $20 million per year
• Delivered 33 blood glucose monitoring and data management systems
• Combined medical device R&D design reviews with Japanese sister company to reduce design review meetings and process overhead by 50% from August 2017 to April 2018

Leverkusen, North Rhine-Westphalia, DE

• Managed R&D compliance engineers, blood glucose meter safety and certification engineers, and IT validation experts. Business owner for 40+ quality system engineering procedures.
• Managed medium sized team (15 - 25 people) in U.S. and India
• Established IT software compliance department and processes
• Delivered 18 blood glucose monitoring systems, 4 contrast media injection systems, 6 tele-health solutions, and over 50 data management software releases across PC, Mac, and mobile platforms
• Spearheaded engineering process improvement project in 2009 – 2010 to reduce medical device R&D in-process defects by 15% and overall R&D cycle-time by 15%
• Implemented FDA Unique Device Identification (UDI) for Class 1, 2, and 3 devices

Bs, Computer Science

Education

Engineering, English, Mathematics

Education record