Fred J. Zuber

Trophy Club, TX 214-***-**** acxfb0@r.postjobfree.com

Customer and quality focused operations executive with 30 years progressive leadership experience in the medical device industry. Solid leadership, strategic planning and communication skills with track record of developing leaders and motivating teams to meet/exceed corporate objectives and customer expectations. Proven ability to adapt to challenging business conditions and lead complex projects to successful outcomes.

PROFESSIONAL EXPERIENCE

PREMIER CONSULTING

TRAINING ADMINISTRATOR June-August 2016

Responsible for conducting error reduction training to Texas Health Resources hospital group employees.

ORTHOFIX - Lewisville, TX ($400M Revenues)

VICE PRESIDENT US OPERATIONS 2013-Nov 2015

Responsible for leadership and strategy for US Supply Chain, Quality, Manufacturing, Operations Engineering, Customer Care, Facilities and Operations Excellence functions for Spine Implant, Bio-Stim, Biologics and Extremities Fixation business units. Annual Operating budget responsibility $29M.

Recent Achievements:

Reduced Operating expenses by 10 % through re-organization of Quality and Operations departments.

Achieved > 99% domestic service level for all GBU’s supported while reducing inventory levels by $17.8M or 18% over 18 month period. International customer on time delivery improved 40% in 18 months.

Supported development and product launch of 4 new Spine implant product lines, 2 IDE studies to expand indications for PMA Bone Growth Stimulator and new business development diligence efforts.

Achieved a 46% reduction in open CAPAs, 30% reduction in product complaint investigation time. Also netted $2.6M reduction in MRB, while reducing inspection backlog by $2.2M.

Operational excellence program (Lean) expanded company wide and netted $377k savings in 2014.

Demonstrated compliance to multiple FDA/ISO/ANVISA regulatory agencies with no critical observations noted. Implemented Unique Device Identifier labeling to meet FDA regulation.

DIRECTOR US OPERATIONS 2006 - 2013

Responsible for management of Manufacturing, Engineering, Operations Excellence and Facilities functions.

Achievements:

Planned and led construction of 145,000 square foot US headquarters and subsequent consolidation of 4 US facilities in 2010 resulting in a $5M reduction in annual expenses.

Initiated Lean cultural transformation in 2011 focused on elimination of waste from Operations, Quality and Distribution processes.

Reduced finished goods inventory by $7M for Spinal Implants in 2010 by implementing Vendor Managed Inventory pull system and supporting sales of legacy products to International Distributors

Lead cost reduction initiative efforts targeted at $2M savings annually. Key projects include vertical integration of spine pedicle screw manufacturing and sterile packaging processes from external suppliers.

Generated over $650K in cost reductions within the Orthopedic Division by transferring the manufacturing of orthopedic products to Orthofix’s sister facility in Verona, Italy.

Championed implementation of Agile/Oracle Product Record software resulting in 20X throughput capability improvement, 50% reduction in ECO processing, and 500% reduction in required manpower.

Implemented surgical equipment cleaning system in returns logistics department that improved capacity by 400% in 2011.

Realized $1M reduction in COGS for Spinal Implants in 2010 by consolidating supplier base.

Successful integration of Blackstone Medical Spinal Implant ($80M) business functions in 2009. Transition included establishment of Orthofix facility as a tissue bank to support biologics distribution.

MANUFACTURING ENGINEERING MANAGER 2000-2006

Provided management direction for 8-12 person Engineering team focused on new product introduction, cost reduction, process development and validation. Operating budget responsibility $500- $800k.

Achievements:

Lead process development activities of next generation bone growth stimulator which resulted in 300% reduction in cycle time.

Supported product development release of first commercially available internal limb lengthening device- ISKD and subsequent vertical integration of assembly and clean room packaging processes from outside supplier resulting in a 50% COGS reduction.

Completed vertical integration of EZ brace post operative brace manufacturing processes from external supplier resulting in 70% COGS reduction.

Successful integration of all business functions of Kenesis Medical including manufacture of Orthotrac pneumatic brace.

Supported product development and successful PMA approval/ release of the first Bone Growth Stimulator indicated specifically for cervical spine.

Successfully converted labeling from pre-printed to print on demand to minimize lead time, inventory, scrap.

Planned and coordinated transfer of manufacturing operations from Richardson, TX to new facility in McKinney TX in 2001. Successfully completed process validations to support PMA supplement approval of site.

Installed and validated the company’s first class 7 clean room supporting sterile packaging of orthopedic fixation devices and Osteogenics maxiofacial bone void filler.

MANUFACTURING ENGINEER 1997-2000

Provided Engineering and packaging design support for Orthopedic External Fixation product lines manufactured at sister company Orthofix SRL Italy.

Successful transition of 3 new orthopedic products into US distribution.

Developed online catalog to assist sales/ internal personnel with proper identification of products

Implemented Instapack system to reduce shipping damage of steri-trays by $100k annually.

PROGRESSIVE ANGIOPLASTY SYSTEMS – Menlo Park, CA 1994-1997

PRODUCTION MANAGER

Coordinated manufacturing activities of FDA Class 3 Angioplasty catheters and stent delivery systems in a start-up company environment.

Manufacturing representative for successful FDA audits to achieve PMA approval of company’s first Angioplasty catheter.

Drove process improvements which resulted in 2X manufacturing output and increased first pass yields by 15% over 2 year period

Designed manufacturing and clean room floor plan for new facility.

OMNI HEARING SYSTEMS/STARKEY LABS – Carrollton, TX 1984-1994

TEAMLEADER

Lead manufacturing assembly team that was responsible for manufacture of custom hearing devices.

EDUCATION

Bachelor of Arts University of Phoenix

Major: Business Management

Associate of Applied Science University of South Dakota

Major: Computer Technology

Six Sigma Green Belt ASQ Certification

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