Bill Ditty Email & Phone Number

Washington, Dc, Us

Oriel STAT A MATRIX provides life sciences organizations with consulting, training, and audit support (including the remote and virtual environment) to achieve compliance with US FDA and global regulations like EU MDR and EU IVDRResponsible for providing Life Science organizations globally with consulting, training, and audit support (including the remote and virtual environment) to achieve compliance with US FDA and global regulations like EU MDR and EU IVDR. Global consulting client support for industry leaders on Quality Management System (QMS) implementation and development for Class I/II/III Medical Device Manufacturers (including Combination Products and some Pharma) Provide onsite and virtual expertise and training on all areas of Life Science subject matter expertise (examples include EU MDR, MDSAP, ISO 14971 Risk Management, ISO 13475 Lead Auditor, CAPA, Supplier Quality, etc.). Subject Matter Expert with Global Medical Device Regulations such as but not limited to US(21CFR820/803/806/Part 4& 11), Australia, Brazil, Canada, Japan, EU MDR/UK, China NPMA (formerly CFDA) with proficiency in India, Taiwan, Thailand, Part210/211, ICH Q series (Combination Products/Pharma), etc. Implemented M&A Due Diligence playbook and led QA/RA research, report and recommendations to C-suite for global medical device company that resulted in $1B+ divesture and sale with carve outs for risk protection Directed development, communication, implementation, and continuous improvement of remote audit program during global pandemic to ensure continued delivery of client audit services to assess compliance to global medical device quality system regulations and standards (when no onsite services available worldwide). Recognized collaborator and communicator, created and led a team to improve global communications from a 81 to a perfect 100 according to Great Places to Work (95 is considered best in class) which was published (2/ 2022)

Mason, Michigan, Us

Oversaw legal, compliance, and global risk management, as well as the portfolio of patents and trademarks. Started as Director of Quality and Compliance, with global responsibility for 12 sites on 2 continents. Promoted to C-level executive in 2013 as Vice President of Quality and Regulatory Compliance and officially assigned to the executive team. Global oversight increased with acquisition to a total of 15 site locations on 4 continents. Led dismissal of five product liability cases and navigated a very difficult FDA inspection.Appointed by the Board of Directors as company officer in 2018 and director and manager for 11 corporate entities, along with additional responsibilities as head of legal, risk management (including commercial insurance), and environmental health and safety. Instrumental in legal role, in addition to quality, compliance, insurance, and environmental health and safety due diligence/interviews for private-equity sale of company to Nordic Capital in 2019, and assumed additional managing director positions.•Collaborated with Board of Directors&private-equity partners on value creation and ultimately sell the company for a healthy investment return for all equity holders.•Presented to the Board of Directors (6x/year) and ad hoc committees as an appointed company officer including evaluation of new/competitive technologies•Collaborated with executive team&board to create pipeline of potential acquisitions•Maintained portfolio of patents and trademarks, negotiated&secured global agreements, partnerships and intellectual property•Provided legal review of contracts and agreements up to $35 million per contract.•Created, directed and managed global quality organization with a entrepreneurial style, implemented talent assessment and management, led 15 senior-level managers (200 total personnel).•Improved quality from 98.4% to 99.5% primarily Class III implantable medical devices, revenue increase of 95%, margin (EBITDA) increase of 7%,

Advanced instructor in Power and Sail with a mission of improving maritime safety and enjoyability through classes. I endeavor to give back to the community wherever I live with the education and skills I have been blessed with while fostering life long interest and/or passion.

Member of Board of Directors and shareholder driving property investment, company formation, development, appreciation, and community involvement.

Consulting, Naval Architecture, and Marine Surveying of Private and Commercial boats, yachts and ships with a passion for ensuring safe design, condition and operation on lakes, oceans and navigable waterways.

Minnetonka, Mn, Us

MONTERIS MEDICAL, INC., Winnipeg, ManitobaDirector of Quality Assurance and Compliance, Manager of Reimbursement Services, 2008-2012Served as executive member of medical device start-up and emerging company (first U.S. hire). Oversaw quality assurance of class I, II, and III medical devices in U.S. and Canada while collaborating with the board, private equity and venture capital partners, the technology founder, the University of Manitoba faculty and all functional areas to get the technology approved by the FDA and to market. Achieved positive Medicare policy decision for reimbursement of laser interstitial thermal therapy. Developed and implemented ongoing policy strategy with Blue Cross Blue Shield, Cigna, and HCSC. Assisted institutions and administrators with development of business plans with proven positive ROIs.•Collaborated with the founders and faculty at University of Manitoba to incubate the idea into commercialization•Provided senior-level leadership and oversight of all medical device pipeline projects and milestones.•Applied for and obtained Medicare new technology add-on payment for three years (only product in 2010).•Assisted with regulatory 510(k) application (cleared May 2009) and completion of clinical trials (IDE).•Negotiated and closed real estate contracts for facilities in Winnipeg, Manitoba, and Kalamazoo, Michigan.•Mentored company executives and peers on strategy development, execution, and technology commercialization•Provided ad hoc assistance to other medical device start-ups in southwest Michigan.

Milwaukee, Wi, Us

Past Chairman guiding current Board and assistance with Membership details

Milwaukee, Wi, Us

Chair, Previously Vice Chair and SecretaryEfforts resulted in following awards including top award possible in 2005/2006:2005-2006: Gold Excellence Award (less than 5% qualified), Total Quality Award (less than 1/3 qualified)2004-2005: Total Quality Award (less than 1/3 qualified)

Kalamazoo, Mi, Us

Oversaw global due-diligence activities to support six M&A deals (mix of acquisitions, mergers, and distributor deals), which totaled more than $80,000,000. Evaluated global products to provide corporate recommendations for potential profitability and liability. Reviewed and implemented on-site business system changes to support immediate sales upon closing deal. Supported sales force and marketing launch plan and presentations, pre-launch and post-launch. Engaged and directed ad hoc members to ensure safety and efficacy of new products to FDA guidelines. Globally established and led new product development efforts with contract manufacturers.

Kalamazoo, Mi, Us

Increased employee engagement (Gallup and Q12) to corporation high of 4.96, with entire unit from 4.1 to 4.47. Led team of up to 38 people to more than $540,000,000 in shipments (on $536,000,000 goal). Filled 99.99% of more than 396,000 orders on time (best in class for corporation). Directed inventory management of more than $30,000,000 to best-ever absolute value of 98.21%. Analyzed trends and decreased shipping complaints 84% to less than 88 defects per million (on goal of under 100). Increased productivity 43% while reducing overtime 4% and finishing $100,000 under budget. Achieved “best unit” at 2006 operations congress.

Kalamazoo, Mi, Us

Assisted with design and development of more than 13 medical devices to replace best-in-class products. Analyzed thousands of lines of data over 13 separate power tools to create quality baseline. Worked with surgeons and six sales representatives to develop trial in operating room and troubleshoot Core Handpieces. Presented and consulted on FDA, ISO, and supplier management topics throughout corporation. Implemented new supplier audit system and risk assessment across corporation. Achieved best-ever power tools launch, on time and with best warranty return rate. Interpersonal skills instrumental to success

POWERLINE INC., Troy, Michigan, Program Manager/QS 9,000 Manager/Quality Engineer, 2000-2003. Planned and directed two major and several minor new product launches in excess of $4,000,000. Led all customer problem-solving efforts for $25,000,000 and five major customers (Tier 1). Directed effort to move from Tier-1 customer’s worst to best supplier in less than six months. Led all management meetings, PCPs, FMEAS’s, and internal audits. Directed company from failed audit to three successful audits). Implemented communication tools to aid in driving down scrap from 20%-to-25% to 1.8% of sales. Served as resident corporate research lead and technical expert for all leak testing applications and analysis.

Washington, Dc, Us

Assistant Section Chief, U.S. Coast Guard Maintenance and Logistics Command, Norfolk, Virginia, 1996-1999. Oversaw three senior officers, one senior enlisted, one civilian engineer, and $11,000,000 in annual engineering funds. Handled construction and delivery oversight of Coast Guard’s newest vessels. Directed quality action team, saving 51 process days and implementing measurements. Managed technical training and workloads of 15 personnel and 120 projects annually. Reviewed requests for shipboard work, ensuring adequate information in development of specifications. Provided quality control to determine additional technical development. Created estimates and specifications for vessel repair bidding in excess of $500,000 per vessel.Type Desk Manager, U.S. Coast Guard Maintenance and Logistics Command, New York, New York, 1994-1996. Chairman for execution of planned maintenance programs, including emergency repair contracts and dry-dockings and dockside repair availabilities for large cutters ($14,000,000 per year). Personally coordinated resolution of major equipment casualties, 95% with same-day action, support, and response ($600,000 to $1,000,000 per year). Oversaw strategic planning of weight-handling conversion, resulting in $120,000 savings, as well as combination dry-dock and dockside availability, resulting in $500,000 savings.Assistant Engineer Officer, USCGC Mellon (WHEC 717)/Auxiliary Division Officer, USCGC Midgett (WHEC 726), Seattle, Washington, 1992-1994. Managed up to three officers, 45 enlisted personnel, and $250,000 annual division budget. Supervised 30 personnel during “high-risk” training evolutions that required critical decisions. Served as hazardous materials coordinator for 378-foot vessel and 180 personnel.

Naval Architecture And Marine Engineering

Mba, Finance

Naval Architecture And Marine Engineering