Robert Hillard

***** *** ******* *********, ***. 315, Nashville, TN 37211

Phone: 615-***-**** E-Mail: ad008s@r.postjobfree.com

www.linkedin.com/in/bobbyhillard

Quality Assurance Manager - Quality Management & Auditing Root Cause Analysis Change Management Attention to Detail

An accomplished and business savvy professional with robust experience acquired over the years in delivering optimal results & business value in high-growth environments and establishing key relationships with business segments globally. Positive, detail-oriented, and self-driven quality professional with 30+ years of comprehensive expertise in developing Quality Management Systems compliant to ISO 9001, ISO 13485 & 21 CFR 820. Skilled in APQP, PPAP, control plans, FMEA, GR&R CAPA, change, complaint, and supplier management. A certified lead auditor with a history of identifying areas of continuous improvement with CAPA accountability. Expertise lies in successfully managing teams, processes, and strategic programs to drive continuous quality improvement efforts through audits and special projects. Possess problem-solving skills utilizing TQM and Six-Sigma (DMAIC) data-driven methodologies. 6 Sigma Green Belt, amassed a breadth of knowledge in analyzing data and orchestrating project implementations, as well as ensuring compliance with local and federal regulations. Enhanced abilities in assessing requirements, investigating and setting up standards, performing actual systems testing, determining problems and needs, and resolving quality assurance issues. Experience in cross-functional team building, data-driven problem solving, improvement, and KPI reporting. Exceptional communication, presentation & interpersonal skills with proficiency at grasping new concepts quickly and productively utilizing the same. A hands-on manager; I take quality to the floor and elevate infrastructure.

~ Leader in the creation of a new Quality Management System for Smile Direct Club compliant to 21 CFR 820 and ISO 13485. Opened a new international market with projected revenue growth of 40-50% ~

~ Implemented lean and effective internal and external audit program for MacDermid Enthone that grew international semiconductor business with projected revenue growth of $2MM in Asian semiconductor market ~

~ Single-handedly submitted successful 510k for Acme Monaco resulting in the new product line with revenue growth over $200K ~

~ Developed best-in-class validation and supplier management program for Mott Corporation ~

~ Company leader in the development of risk management, validation and design process for Mott Corporation to open up a lucrative medical device market with compliance to ISO 13485 ~

Skill Areas: Strategic & Operations Planning Quality Management & Auditing Supplier & Laboratory Management Root Cause Analysis Change Management Training Complaint Management Process Improvement Strong Interpersonal Skills Analytical Skills Team Management Communications Critical Thinking Problem-Solving Time Management Attention to Detail Client Relationship Management Innovation Leadership Management Skills Lean/6-sigma Experienced Manager of Staff Presentation & training skills

PROFESSIONAL EXPERIENCE

Wonder Porcelain, Lebanon, Tennessee (Jun 2021 – Present)

Quality Assurance Manager

American Wonder Porcelain is a Chinese owned manufacturer of fine porcelain tile, with sole North American location in Labanon, TN.

Developing a new ISO 9001:2015 Quality Management System from scratch. Manage 2 QA Technicians.

In short time, developed and implemented Document Control, Change Control, CAPA and Complaint Management..

Developed and currently implementing detailed internal audit program.

Wrote SOP and Manage all complaints, to include, root-cause investigation (CAPA), and customer reporting. New process has saved company in excess of $200,000 from 2022 to present. Highly praised by leadership.

Company representative to Tile Council of North America and leader for all Green-Squared certifications.

Amazon Fulfillment, Bna2, Lebanon, Tennessee (Jul 2019 – May 2021)

Inbound Product Associate/Hazardous Material Associate

Amazon.com, Inc. is an American multinational conglomerate technology company based in Seattle, with 750,000 employees.

Perform duties pertaining to inbound product receipt, inspection, and preparation for stow and outbound sale

Performed profiling and disposition/disposal of hazardous waste and damages generated in the Amazon facility.

Selected by leadership as a member of Covid-19 compliance efforts to allow the essential business to maintain services while ensuring associate safety. Oversee the Covid-19 testing of associates, ensure compliance of test kits for testing and shipment and lead recruiting efforts which has led to the #1 regional facility at Amazon for test completion.

Smile Direct Club/Access Dental Lab, Nashville, TN (Jan 2018 – Jan 2019)

Quality Assurance Manager

Founded in 2014, SmileDirectClub now represents 95% of the doctor-directed at-home clear aligner industry. We've helped over a million people transform their smiles – their before and happily ever after photos speak for themselves.

Responsible for the development and implementation of a new quality management system compliant to 21 CFR 820, ISO-13485:2016 and MDSAP. QMS developed from scratch in one year.

Regularly analyzed quality data and suggested actions based on collected data

Managed the log of quality reports and other quality documentation

Developed and trained Internal Audit, Change Management, CAPA and cGMP training processes successfully

Developed, performed and documented the first internal audits in the organization’s history. Well-met by leadership

Developed complex customer complaint process, to successfully manage the many daily inquiries and complaints

Led training successfully to all facets of the corporate structure in the area of QMS, ISO-13485 and GMP.

Implemented internal auditing, change control, CAPA, and customer complaint processes. Managed 3 customer complaint coordinators

Left company in very good standing to take personal hiatus in 2019 – Aging family care and volunteer activities.

Macdermid Enthone, Inc., West Haven, CT (Feb 2015 – Jan 2018)

Quality Assurance Manager

As a part of MacDermid Performance Solutions – the global Leader in specialty chemicals and technical services – MacDermid Enthone Industrial Solutions is a pioneer in surface finishing chemicals. By innovating and manufacturing chemical compounds for all surface coating applications, MacDermid Enthone Industrial Solutions improve the durability and aesthetics of metal and plastic surfaces

Pioneered the efforts across handling the entire gamut of functions about quality management system compliant to ISO-9001:2008 and ISO 9001:2015.

Developed, implemented, and managed processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery, to include SPC review, specification development and sustainability.

Identified and set appropriate quality standards and parameters for products based on capability studies

Communicated QMS standards and parameters to entire site, to include production, engineering and R&D.

Developed and led leaner, more effective Management Review meetings. Organized first Management Review for ISO 9001 certification audit after only 3 weeks on-board. I built teams, analyzed/closed significant gaps and passed audit successfully

Improved CAPA closure/effectiveness verification rate from 36% to 98% in less than 1 year

Significantly enhanced internal audit program. Trained audit teams and elevated audit executions from 12 to over 70 in 1 year.

Left company in good standing to make life move to Tennessee

Mott Corporation, Farmington, CT (Feb 2012 – Dec 2014)

Director of Quality Programs

Mott is a high precision filtration and flow control company trusted by the world’s best known technical and performance brands. Often, our customers have no effective options to solve their challenging problems. Our strategic vision is to deliver technological breakthroughs where none currently exist.

Oversaw all quality assurance efforts within the organization, including the development and implementation of a quality assurance program compliant to ISO-9001.

Ensured that all procedures within the company conform to health and safety regulations, financial policies and legislation, working closely with new product development, production, sales and procurement functions.

Leaded development of formal validation, risk management and design procedures for a new medical device product line, to include cleaning validations and IQ/OQ/PQ of all equipment and processes per FDA harmonized guidance and cGMP requirements

Co-developed new vendor qualification program recognized as world-class by the ISO registrar

Accountable for all APQP processes to include PPAP, FMEA, GR&R and product warrants. Improved FMEA process to focus on true risk and measurable mitigations. Followed AIAG PPAP and FMEA guidance

Leaded cross-functional teams on complex issues for semiconductor customers which resulted in a 10% revenue growth, enhanced capabilities and increased customer confidence in our company

Demonstrated quality management system requirements to TS 16949, AS9100 and NQA-1 when required for specific customers

Developed and led more effective/leaner annual Management Reviews with the overwhelming approval of the leadership

Assisted in the development, monitoring, and presentation of internal quality measures and initiatives

Positon eliminated in 2014 due to corporate restructuring. Left company in very good standing.

Acme Monaco Corporation, New Britain, Ct (Jun 2010 – Jan 2012)

Manager of Quality and Medical Device Compliances

Acme Monaco was founded as Acme Spring, Incorporated in 1947. Founder, Harold Davies was tasked with developing a miniature ring for the New Departure Division of General Motors. In the 1950's and 1960's Acme expanded with miniature bearing ring enclosures as its industry flourished with advances in U.S. technologies of aeronautics, defense, motion controls, and rapid advances in small machinery.

Ensured that all company products and services meet quality standards before they go to market

Implemented improvements to production processes that lead to overall increases in product quality

Handled maintenance and improvement of a quality management system compliant to ISO 9001 and ISO 13485 Enhanced internal audit and CAPA programs significantly

Developed all testing protocols and submittal requirements for A 510K to the satisfaction of the FDA

Opened a new product line for the company with a projected $200K revenue growth

Responsible for quality control and assurance of the medical guide-wire assembly process

Project manager for Basis of Design and contractor selection for a new cleanroom for medical device manufacturing

Demonstrated compliance with AS9100, to include all automotive APQP and PPAP processes for GM subcontractors

Acted as a catalyst for change and improvement in performance and quality with the development of new testing and cleaning processes for medical guidewires and associated hardware sold to pharmaceutical industry.

Worked effectively with others in a team based environment to accomplish organizational goals and to identify and resolve problems

Established and implemented short- and long-range goals, objectives, policies, and operating procedures

PRIOR EMPLOYMENT DETAILS

United States Coast Guard Academy, New London, Ct Aug 2009 – May 2010

Lecturer in Chemistry

Talsico Llc, Martinsville, Nj Nov 2008 – Aug 2009

Quality System Consultant

Left due to downturn in pharmaceutical market.

Orasure Technologies, Inc., Bethlehem, Pa Aug 2006 – Nov 2008

Quality Assurance/Validation Manager

Continuous Improvement Team Leader

One of many positions eliminated in 2008 Left in good standing.

Gow-Mac Instrument Company, Bethlehem, Pa Jan 1999 – Aug 2006

Chief Chemist

Chromatography R&D, publications, sales, international installation & consultation.

Developed applications for worldwide customers. Published technical articles on R&D,

Presented at formal conferences nationwide.

Northampton Community College, Bethlehem, Pa Jul 1997 – 1998

Marketing Manager / Chemist

Marketing positon eliminated in 1998 due to energy industry deregulation. Left in good standing.

Praxair (Formerly Liquid Carbonic), Bethlehem, Pa 1990 – 1997

Quality Manager

Single handedly developed and implemented first ISO 9000 QMS for the facility.

Managed laboratory for largest specialty gas facility in North America

United States Air Force – Active Duty (2nd Lieutenant, 1st Lieutenant, Captain) 1980 – 1989

Assistant Professor of Chemistry US Air Force Academy as Captain.

Coourse Director, Program Leader, Chosen to teach advanced course.

Northampton Community College, Bethlehem, Pa (Part-Time; After Work Employment) 1990 – 2009

Adjunct Professor of Chemistry. Wrote and implemented new course for college.

PROFESSIONAL DEVELOPMENT & CREDENTIALS

Northeastern University, Boston, Massachusetts Master of Science in Chemistry (ACS Certified)

Virginia Military Institute, Lexington, Virginia Bachelor of Science in Chemistry (ACS Certified)

Certified Quality Engineer American Society for Quality (Cert # 50631)

Assistant Professor of Chemistry U.S. Air Force Academy, 1988

Certified Lead Assessor of Quality Systems Perry Johnson, Inc, 1995 (Cert #4701951)

Total Quality Management & Facilitation Certificate QMI/Liquid Carbonic, 1993

Six Sigma Green Belt Central Connecticut State University, 2012

Technical Publications Multiple and available upon request. International journals.

Technical Skills: Microsoft Office Suite and Internet, various SPC and QMS platforms.

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