DON HUBER

**** ***** ****** acz44t@r.postjobfree.com

Cincinnati, OH 45208 linkedin.com/in/donhuber1

513-***-****

SUMMARY

Quality Assurance and Product Integrity Manager with extensive experience in the areas of quality management system development, industry-wide safety standards development, regulatory compliance, risk management, hazard analysis and prevention, verification and validation testing, and test laboratory management. Industry experience includes juvenile products, toys, medical devices, and consulting.

Regulatory Compliance

Consumer Complaint & Returns Data Trending

Management of Product Integrity Team

Internal Policies & Procedures Development

Verification/Validation Test Protocols

Root Cause Analysis & Corrective / Preventive Action

Regulatory Agency Reporting

Risk Assessment & Hazard Prevention

Recall and crisis management

FDA 510(k) submissions for Class I & II medical devices

DELOITTE & TOUCHE LLP, Cincinnati, OH 2012 – 2016

Manager, Product Safety & Quality

Assisted Managing Director to build start-up practice for the firm, achieving $5,000,000 annual revenue. Provided subject matter expertise to Deloitte clients through the performance of assessments and benchmarking of their product compliance, safety, and quality programs against leading practices, and assisted them in development of strategic solutions for addressing any gaps identified to reduce the potential for brand and reputation damage. Helped manufacturers to mitigate risk of incurring costly civil and criminal penalties and product liability lawsuits by applying experience in identifying potential hazards in new product designs, development of effective pre-launch product qualification testing protocols, assessment of post-launch consumer data, and determination of the need for regulatory reporting.

Led multiple projects with total revenue of more than $1,700,000.

Directed project to assess the food safety program for a large grocery retailer, including coordination of an in-depth review of the corporate food safety program policies and procedures, and an assessment of the level of compliance to the food safety program at store locations.

Managing two Consultants, oversaw performance of a comprehensive assessment of global sporting goods company product integrity and product testing programs in North America and Asia.

Using a third-party service provider, enhanced international bedding manufacturer’s process for identifying global chemical compliance requirements, assessing chemical compositions for compliance to regulations, and horizon scanning for new and emerging regulatory requirements.

Developed marketing materials and eminence publications for promotion of the Deloitte Advisory Supply Chain Risk Management portfolio of services.

Collaborated with Deloitte Advisory’s Internal audit teams as Subject Matter Expert to assess the product integrity programs of toy and juvenile products manufacturer, and a major technology company.

Acted as a member of the Deloitte Advisory faculty as a facilitator of the Experienced Hire Onboarding course and other Deloitte University courses.

EVENFLO COMPANY, INC., Miamisburg, OH 2001 - 2012

Director, Product Integrity (2005 – 2012)

Directed and managed primary product and quality function during product development for leading juvenile products and adult medical device manufacturer. Coordinated efforts to assure regulatory compliance, safety, reliability, and quality of product designs. Oversaw Product Integrity Engineering team including a Manager and four Engineers, and PI Test facility comprised of a product testing laboratory and child restraint system crash test laboratory staffed by a Manager and six Test Technicians. Managed and maintained more than $1,000,000 annual budget.

Achieved 60% reduction in quality-related consumer calls and 50% reduction in retail customer defective returns rate through effective development of policies & procedures and test specifications, and rigorous verification and validation testing.

Drove modification of ASTM International Safety Standards for Hand-held Infant Carriers and Stationary Activity Centers for Notice of Proposed Rulemaking within mandated Consumer Product Safety Commission timeframe.

Conducted compliance reviews with product development team regarding new and revised regulations and safety standards for products ensuring compliance by the effective date.

Eliminated hazards from product designs through organization-wide training in Designing for Safety policies and practices.

Upgraded policies and procedures and test protocol template to assure compliance with retail customer and international requirements.

Charter member of team that assessed trending of field complaint data to determine appropriate Corrective and Preventive Action(s), and achieve timely regulatory agency reporting.

Provided essential support for FDA inspections and ISO 13485 notified body audits for maintenance of medical device certifications, with no significant findings of nonconformity.

Developed and maintained KPIs that reduced temporary deviations by 70%, increased first sample approval rate by 30%, and resulted in on-time completion of internal & third-party testing for demonstrating compliance to CPSIA requirements.

Manager, Product Integrity (2002 – 2005)

Managed four-member engineering team. Configured and maintained Product Integrity and Quality documentation used for demonstrating conformity to regulations and standards.

Coordinated revisions to Product Integrity policies & operating procedures to reflect regulatory and juvenile products industry standards updates to prevent placing on the market nonconforming products.

Effectively administered department spending for adherence to $400,000 annual budget.

Trained HQ, Mexican, and Asian Evenflo staff in use of policies & procedures to ensure consistent application and interpretation of requirements and test methods.

Administered internal, 3rd party, and retail customer verification & validation testing to accomplish on-time delivery of compliant products.

Participated in development and maintenance of ASTM International juvenile products safety standards.

Chair of Hand-held Infant Carriers and Stationary Activity Centers ASTM subcommittees.

Sr. Engineer, Product Integrity (2001 – 2002)

Acted as Product Integrity representative on cross-functional product development teams. Established product design verification & validation testing protocols, and coordinated associated testing.

Participated in development of Product Integrity policies and operating procedures incorporating regulatory requirements, juvenile products industry standards, and Evenflo internal standards.

Created and implemented customized verification and validation test protocol template to provide users with a consistent format for test protocols.

Developed framework for Product Integrity intranet webpage for use by entire organization for viewing and downloading policies, procedures, test protocols, and other Product Integrity -related knowledge.

Delivered training of Headquarters, Mexican, and Asian Evenflo staff in use of test protocols, achieving consistent application and interpretation of requirements.

KENNER PRODUCTS / HASBRO, Cincinnati, OH 1990 – 2000

Sr. Project Engineer – Reliability (1990 – 2000)

Responsible for assuring regulatory compliance, safety, reliability, and quality of product designs from concept to end of life. Oversaw associated verification and validation testing of assigned products.

Developed product safety and reliability test specifications to support verification & validation testing.

Coordinated verification & validation testing to demonstrate conformity to US and international toy regulations and standards, and facilitate on-time delivery to market.

Supported product launch efforts at domestic factory and on site at Mexican and Asian supplier factories.

Supervised administrative associates.

EDUCATION

Master, Business Administration, Quality Improvement

Xavier University, Cincinnati, OH

Bachelor of Science, Mechanical Engineering

University of Cincinnati, Cincinnati, OH

PROFESSIONAL DEVELOPMENT

Certified Child Passenger Safety Technician

21 CFR 820 Quality System Regulation Training

Failure Modes and Effects Analysis (FMEA) Training – design & process

COMPUTER and SOFTWARE SKILLS

Microsoft Office Suite - 2016

PROFESSIONAL ACTIVITIES

ASTM International Committee F15 Consumer Products

Chair, Stationary Activity Centers ASTM Subcommittee

Chair, Hand-held Infant Carriers ASTM Subcommittee

American Society for Quality, Cincinnati Section

Member, American Apparel & Footwear Association Product Safety Council

Member, International Consumer Products Health & Safety Organization

COMMUNITY ACTIVITIES

Mentor at Oyler School, Lower Price Hill, Cincinnati, OH

Miami Valley Roy Hobbs Senior Baseball League

Advisor for Alpha Xi Chapter of Pi Kappa Alpha Fraternity

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