Steven B. Downing Email & Phone Number

Rhode Island, United States

Developed and strengthen a multi-site quality organization as well as repairing strained customer relationships. Developed a “One Quality Voice” that was essential to the quality organization success. Appreciably improved customer relations that collaboration between LM and customers is natural. Responsible for leading quality operations for eleven US facilities. Led successful efforts to return programs to favorable status.

Houston, Texas

Fortune 200 Company. Quality and Regulatory Affairs Director superintending eight North American RRD Global Turnkey Solutions (GTS) facilities. RRD GTS serves technical, telecommunication, medical device, food and nutrition, and consumer product corporations. Lead several new business project teams that on-boarded several medical device and nutrition business growth opportunities into our GTS facilities. GTS customers include HPE, Kyocera, Zagg/Mophie, Beck and Dickinson, Bayer/Ascensia, Abbott Diabetes, Abbott Nutrition, Coloplast, BioFilm, and other industry market leaders.

New Bedford, Ma

Direct report to President and CEO. Provided company wide leadership and management for the quality and supplier development function. Achieved corporate responsibility for providing technical and quality leadership to sales and marketing, engineering, and manufacturing operations through the creation, development, implementation, and monitoring of quality management, business management and continuous improvement systems. Role expanded to include management of global Technical Service Organization and New Product Development teams. Active participant in quarterly Board of Directors meetings.

Led product, process and quality management systems for Coto’s manufacturing plants in the US, Mexico, and The Netherlands. Reported to President and updated DKM’s CEO quarterly. Role expanded to include sustaining engineering. Member of Coto’s Executive Steering Committee leading strategy development for overall improvement of automation, new technology, outsourcing, and state-of-the-art products.

Charged to reduce time to market and to lead rapid expansion into global markets. Managed quality aspects of new product development and sustained product quality for medium- and high risk products. Held full product life cycle responsibilities including design verification testing (DVT), pre-market international product approvals, retailer and end-user interaction. Managed international business affairs and held responsibility for contract manufacturing, offshore manufacturing sites and warehousing. Key contact for regulatory agencies and third party notified bodies.