Curtis Woods

Experience

• 

  Fresenius Medical Care North America

  Jan 1995 - now

  — Expert oversight of a 24/7 Technical Team, in charge of professional service operations including technical training, technical customer service/support, and field technical staff— Conceptualization of capital expenditure plans as well as short- and long-term initiatives for resource planning and budget administration, — Implementation of strategic plans to generate objectives, staffing requirements, and succession plans for improvement of retention rates within the company— Development of annual operating plan, quarterly business review process, quarterly financial forecasting, and financial advisory to the business in collaboration with the Finance Team— Creation and monitoring of key performance indicators (KPIs) to guarantee the achievement of long-term objectives— Compliance with regulatory requirements by spearheading various local, corporate, and regulatory agency audits— Strict adherence to reporting needs of the governing regulatory agencies, while generating plans and training requirements for safe product removals from the field— Cultivation of productive relationship with staff members to promote awareness of trending issues— Transition of new products to ensure simplification of service needs in partnership with Quality Systems, Research and Development, Engineering, and Marketing departments— Preparation and management of budgets and KPIs monthly to assess performance to plan variances and identify corrective/preventive actions— Commendation for skills in introducing the best practices that ensured compliance with regulatory bodies (21CFR 820, ISO 13485) under the MDSAP program— Transitioned Call Center to a Work from Home Environment and improved efficiency by 30%— Upgraded CRM system to Salesforce CRM— Upgraded Phone System to Nice InContact Show less — Spearheading of production and engineering operations for a leading global medical device company, including management of 120M value of production and $50M worth of budget— Supervision of the Production and Process Control Team in implementing and upgrading production controls— Administration of the front room during a six-week FDA inspection which resulted to zero findings in 483 observations— Installation of a second shift assembly operation; thus boosting production capacity by 50% Show less — Expert oversight of cross-functional projects in collaboration with several conglomerates in Schweinfurt, Germany— Member of the CAPA review board and material review board, accountable for enforcing, assessing and approving CAPA’s and NCRs— Integral role as risk manager, in charge of reconstructing the company’s risk management system in six months for an FDA inspection— Spearheading of quality improvement projects; thereby minimizing customer returns by 30% and yielding approximately $5M yearly— Driving of efforts to accomplish multiple cost-saving projects that generated more than $4M in savings Show less

  • Director Technical Services

    May 2018 - now

  • Senior Engineering Project Manager

    Jan 2016 - May 2018

  • Director of Production

    Aug 2014 - May 2018

  • Sustaining Engineering Manager

    Sept 2011 - Aug 2014

  • Technical Support Manager

    Feb 2005 - Aug 2011

  • Research & Development Validation Coordinator

    Sept 1999 - Feb 2005

  • Research and Development Validation Coordinator

    Sept 1999 - Feb 2005

  • Chief Technician

    Jan 1999 - Sept 1999

  • Final Test Technician

    Apr 1998 - Jan 1999

  • Quality Control Mechanical Inspector

    Jan 1995 - Apr 1998