Quality Supervisor

Shannon Henderson

Email: *******@*****.*** Houston, Texas 77082 Phone : 214-***-****

Quality Auditor/ Quality Compliance Officer/ Quality Recall Specialist/Quality Manager

(Process Improvements, Quality Assurance, Action Driven-Leadership)

Critical thinker with 8 years of comprehensive supply chain experience with an emphasis in quality and logistics. Leader in

change management attributing to quick learning abilities and contribution to a private company’s IPO. Extremely organized

professional who obtains analytic skills for process improvement, complex problem solving and focused solutions.

ISO 13485 Internal Auditor, Lean, Kaizen, MS Excel, Word, PowerPoint, Microsoft Dynamics Great Plains ERP System, Trend

Professional Experience

Derma Science, Inc. Houston, Texas May 2013- Sept 2013

(CONTRACT)

Derma Sciences is a fully integrated manufacturer and supplier of specialty medical device/pharmaceutical company

focused on wound care.

Quality Control/Assurance Supervisor

• Supervising and training QC Inspectors/QA Technicians and all facility personnel in Quality System Regulations

(cGMP-21 CFR part 820), continuous quality improvement and incoming finished goods inspections.

• Responsible for the daily activities of the QA personnel to insure compliance with GMP requirements with

manufacturer in China and Toronto.

• Assists with the development, implementation, and maintenance of the facility quality assurance program and facility

regulatory affairs.

• Conducted and coordinated cGMP audits of the facility, vendor audits and third party audits to ensure compliance with

regulatory requirements.

• Investigated customer complaints, failure reports, non-conformances, CAPA’s, and corrective action implementation.

Tornier, Inc. Stafford, Texas April 2008-

Jan 2013

Tornier is a global medical device company who currently sells over 90 product lines in approximately 35 countries with sales

approximately $275 million annually.

Quality Assurance Supervisor (2010-2013)

Customer Service Representative (2010)

Logistics Inventory Auditor (2008-2010)

Quality Supervisor responsible for quality distribution team of 6 inspectors and technicians in an intensely fast pace, high

growth organization that has consistent revenue growth and new product launches quarterly.

Worked closely with project management, operations, and development teams to ensure compliance of quality management

systems based on ISO 13485 regulations. Assigned work, managed special projects, trained, reviewed staff inspections,

calibration schedule, product labels and ensured quality products were provided to the customer while ensuring facility is

complainant with processes and procedures established for all FDA regulations and ISO 13485 standards

Shannon Henderson Page 2

Project Highlights, Performance Improvements and Achievements

• Increased service and accuracy levels by working on corporate and local quality harmonization and ISO 13485

implementation resulting in successful ISO 13485 audits.

• Facilitated problem solving using root cause analysis and orchestrated corrective action utilizing analytical tools such

as the “Five Whys” and “Cause and Effect” tools accompanied with exceptional communications and influencing skills.

• Assisted with Medical Device Correction and Removal processes in accordance to 21 CFR 806 & part 7 and 21 CFR

810 from notifying, scheduling, documenting and reporting.

• Communicated with all involved parties internally and externally for Field Action when applicable.

• Complied data and documented the process and progress of Correction and/or Removal of results for Class II and Class

III devices

• Reorganized quality department for more efficiency of processes within the limited space provided since growth was

too rapid to purchase a new building reducing inspection errors by 50%, product recall by 35% and the overall use

of the Material Review Board.

• Key supervisor to assist in the re-location of the quality department from Stafford, TX to Bloomington, MN.

Responsible for training new quality department and physical movement of $5 million dollars quarantine inventory

and quality equipment while maintaining exceptional service level.

• Streamlined Custom Order inspection and fulfillment to support $2 Million in revenues.

• Implemented project that reduced corporate inventory loss reserved by 30%, eliminated duplicate wasteful work and

modernized the downstream distribution systems by implementing a fully integrated mobile sales and inventory

management software system across 28 third party distributors which was a key requirement for the 2011 IPO.

• Provided the central portion of the United States, all international customers for the United Kingdom, Austria, and

Germany with product information, scheduling, pricing and P.O. retrieval.

• Trained for new rollout projects for quality and distribution personnel producing an expert of the business processes for

the field and non conforming material handling.

Stock Building Supply Houston, Texas June 2006-

April 2008

Stock Building Supply is a leading building materials and solutions company for professional homebuilders and contractors for

single- and multi-family residential, repair and remodel and light commercial construction in the United States generating over

$1 billion in annual revenues currently owned by The Gores Group, LLC.

Office Manager - Responsible for all scheduling for sub-contractors, internal employees and materials for jobs, accounts

receivable and payable, purchasing supplies, inputting estimates into our ERP system. Lead communication with the customer,

Installed Sales Manager, and all vendors for various projects at every stage of the project.

• Co-developed and implemented the procedures for the company’s new business venture of the Installed Sales

which added to their portfolio for an unexplored niche in the industry and simultaneously became a major selling

feature for the sales force increasing revenue.

• Solely operated the complete office of installed sales creating new processes for estimates, ordering materials and

scheduling crews and meeting deadlines requiring extreme organization skills and calculated execution to provide the

customer with exceptional customer service.

Shannon Henderson Page 2

Education

Stephen F. Austin State University Nacogdoches, Texas

May 2006

Bachelor of Business Administration

Major: Business Management

Minor: Psychology

Professional Development

ISO 13485 Internal Auditor Certification Houston, Texas

January 2013

Certified Associate in Project Management (CAPM) Houston, Texas

Currently Pursuing

Professional References available upon request

Available to travel

Contact this candidate