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“It’s not about having the right opportunities. It’s about handling the opportunities right.” - Mark HunterA seasoned and highly accomplished 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. I am a confident, 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. I am skilled in APQP, PPAP, control plans, FMEA, GR&R CAPA, change, complaint, and supplier management. I am a certified lead auditor with a history of identifying areas of continuous improvement with CAPA accountability.My expertise lies in successfully managing teams, processes, and strategic programs to drive continuous quality improvement efforts through audits and special projects. My problem-solving skills are utilizing TQM and Six-Sigma (DMAIC) data-driven methodologies. 6 Sigma Green Belt. I have amassed a breadth of knowledge in analyzing data and orchestrating project implementations, as well as ensuring compliance with local and federal regulations. I have enhanced my abilities in assessing requirements, investigating and setting up standards, performing actual systems testing, determining problems and needs, and resolving quality assurance issues. I am experience in cross-functional team building, data-driven problem solving, improvement, and KPI reporting.My remarkable leadership and interpersonal skills let me communicate with upper management and team members. I am confident in delivering impeccable results through my dedication to handling multiple functions and activities under high-pressure environments & tight deadlines. Areas of Expertise: Strategic & Operations Planning Quality Management & Auditing Supplier Management 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 Administrative Skills
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Quality Assurance ManagerWonder Porcelain Group, Llc Jun 2021 - Feb 2024Lebanon, Tennessee, United StatesI am developing a Quality Management System for a manufacturer of fine porcelain tile at their sole North American location in greater Nashville, TN. There were no elements of a QMS, and in a short time, I developed documented processes for Management of Change, Document Control, CAPA, Supplier Management, Internal Auditing, Incoming Inspection and Complaint Management. The new Complaint Management program was implemented and maintained single-handedly, and has saved the company over $200,000 since early 2022 with no compromise in customer satisfaction. I lead the company sustainability program (Green Squared) and manage all aspects of the Environmental Product Declaration. I am the technical committee representative for the Tile Council of North America (TCNA) where sustainability mprovements and universal tile testing applications are being developed. -
Inbound Product AssociateAmazon Fulfillment Jul 2019 - May 2021Lebanon, Tennessee, United StatesMember of Inbound Team responsible for the intake, inspection as well as the virtual and physical receipt of thousands of products received from vendors. Also perform product preparation tasks which render received goods ready for sale. The Inbound team makes the quality decision for product to be received, stowed for picking and eventual shipment to customers. Promoted from temporary to full-time Amazon team member on first day of eligibility. Selected by Amazon leadership to lead implementation and enforcement of Covid-19 compliance efforts to ensure associate safety and maintain business continuity of our essential fulfillment facility.
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Quality Assurance ManagerSmile Direct Club/Access Dental Lab Jan 2018 - Jan 2019Greater Nashville Area, TnI was responsible for the development and implementation of a new quality management system compliant to 21 CFR 820, ISO-13485:2016 and MDSAP. Regularly analyzed quality data and suggested actions based on collected data. I managed the log of quality reports and other quality documentation, ensured the quality and sustainability of production processes. Investigated customers' needs and want and develop a strategy for meeting their needs. I provided training successfully to all facets of the corporate structure, unaware of ISO/FDA requirements. I implemented internal auditing, change control, CAPA, and customer complaint processes managed 3 customer complaint coordinators. Efforts led to successful ISO 13485 certification.
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Quality Assurance ManagerMacdermid-Enthone Advanced Electronic Solutions Feb 2015 - Jan 2018West Haven, CtI 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 the required specifications for quality, function, and reliability prior to delivery. Identified and set appropriate quality standards and parameters for products. Communicated quality standards and parameters to the QA team, product development team, and other appropriate staff. Developed and led leaner, more effective Management Review meetings, organized the 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
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Director Of Quality ProgramsMott Corporation Feb 2012 - Dec 2014Farmington, CtI oversaw all quality assurance efforts within an organization, including the development and implementation of a quality assurance program. I ensured that all procedures within the company conform to health and safety regulations, financial policies, and legislation. 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 automotive/transportation APQP processes to include PPAP, FMEA, GR&R, and product warrants. I improved the FMEA process to focus on true risk and measurable mitigations. I 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. I 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 leadership and assisted in the development, monitoring, and presentation of internal quality measures and initiatives. -
Manager Of Quality And Medical Device ComplianceAcme Monaco Corporation Jun 2010 - Feb 2012New Britain, CtI have ensured that all company products and services meet quality standards before they go to market. I implemented improvements to production processes that lead to overall increases in product quality. I handled the maintenance and improvement of a quality management system compliant to ISO 9001 and ISO 13485. Enhanced internal audit and CAPA programs significantly. I developed all testing protocols and submittal requirements for a 510K to the satisfaction of the FDA. I 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. I acted as a catalyst for change and improvement in performance and quality.
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Lecturer In ChemistryU.S. Coast Guard Academy Aug 2009 - May 2010New London, CtA temporary teaching assignment at one of our service academies that helped us realize our dreams of moving to Connecticut and being closer to our kids. A wonderful year, which led to my contract being extended, however I declined in order to accept a full-time position in industy. -
Quality System ConsultantTalsico Llc 2008 - 2009New JerseyPresented Seminars to pharmaceutical companies in USA and Europe on the subject of CAPA, human error analysis and error investigation and diagnostics.
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Quality Assurance ManagerOrasure Technologies Aug 2006 - Nov 2008Bethlehem, PaManaged the validation and QA functions for ISO 13485 compliant quality system. -
Chief ChemistGow-Mac Instrument Company Jan 1999 - Aug 2006Bethlehem, PaManaged gas chromatography R&D, application development and technical consulting for this chemical analysis instrument manufacturer. Published articles and delivered many scientific papers on chromatographic detector technology and new products in support of business growth effort.Publications in support of GOW-MAC business growth:Hillard, R.M., The Discharge Ionization Detector, International Instrumentation & Automation, Vol. 6, No. 9, 2002, pp. 64-66.Hillard, R.M., Process Gas Analysis using Thermal Conductivity Detectors, Cryogas International, Vol. 41, No. 7, July 2003, pp. 36-37.Hillard, R.M., Statistics in the Specialty Gas Laboratory: Critical Tools for Winning the Audit and Getting the Sale, Specialty Gas Report, Vol. 8, No. 3, Third Quarter 2004, pp. 52-57.Hillard, R.M., The Determination of Trace Impurities in High Purity Oxygen, Cryogas International, Vol 43, N0. 4, April 2005, pp. 40-42.Hillard, R.M., Fincke, K.B., Nitrogen Analyses of HP Argon by Emission Spectroscopy Applied to Labs and Processes, Specialty Gas Report, Vol. 9, No. 1, First Quarter 2006, pp. 22-27.
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Quality ManagerLiquid Carbonic/Praxair 1990 - 1998Harrison, Nj/Bethlehem, Pa•Quality Manager - Developed and wrote entire Quality plan for new national specialty/medical gas operations center. Maintained FDA compliance for medical products and devices. Implement lean and variation reduction processes.•ISO-9000 Project Manager and Management Representative for Quality. Developed quality manual, procedures, work instructions as well as audit, training and implementation plans for ISO-9002 certification including evaluation and management of suppliers. Effectively implemented, trained and audited the entire quality system, established cross-functional teamwork, and led facility to become a preferred supplier to major semiconductor customers. Leader for all customer and agency audits.•Laboratory Manager- Co-Developed and managed the analytical activities for over $200K monthly specialty gas mixture and high purity products for semiconductor, medical, pharmaceutical and emissions monitoring industries. Supervised eight professional chemists. Developed and managed Quality Control processes to include SPC, calibration, CAPA and lean flow.•Developed and implemented a complete Statistical Process Control program for state-of-the-art facility, which includes all major product lines, as well as laboratory and production performance characteristics and ANOVA.•Business Development - Made frequent formal presentations to customers in support of sales and business growth. •Served as Inside Technical Sales Representative- Developed cost and pricing schedule for all products; national consultant.•Formally trained in tools and methodology of Total Quality Management; Coordinate/lead all plant process improvement teams.•Director of training for quality, compliance, procedure implementation and variation reduction (six-sigma).
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Assistant Professor Of Chemistry, Us Air Force AcademyUnited States Air Force 1985 - 1990Colorado Springs, Colorado AreaActive duty military officer. Taught General, Advanced Physical and Analytical Chemisty to America's best and brightest. Served as Course Director for Quantitative Analytical Chemistry program. Selected to teach new Quantum-based chemistry course to advanced level cadets. Chairman of USAF Summer Scientific Seminar for Chemistry department. Chosen as lecturer in Analytical Chemistry for United States Chemistry Olympiad.
Robert M. Hillard Skills
Robert M. Hillard Education Details
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Chemistry -
Chemistry
Frequently Asked Questions about Robert M. Hillard
What is Robert M. Hillard's role at the current company?
Robert M. Hillard's current role is Quality Assurance professional with over 30 years of experience in all facets of the ISO 9001 and ISO 13485 spaces, to include program development, implementation, training, validation and system maintenance..
What is Robert M. Hillard's email address?
Robert M. Hillard's email address is bh****@****uno.com
What is Robert M. Hillard's direct phone number?
Robert M. Hillard's direct phone number is +120336*****
What schools did Robert M. Hillard attend?
Robert M. Hillard attended Northeastern University, Virginia Military Institute.
What skills is Robert M. Hillard known for?
Robert M. Hillard has skills like Iso 13485, Capa, Quality System, Validation, Fda, Medical Devices, Gmp, Six Sigma, Quality Assurance, 21 Cfr Part 11, Lean Manufacturing, V&v.
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