Quality Engineer

Claire Tessier ***** Cliffwood, Houston, TX ***** Mobile: (713) 992 – 6028 ******-*******@*******.***

Lean Manufacturing / Lean Six Sigma Green Belt

ISO 9001/17025/ASTM/ASME/Compliance

Corrective / Preventive Action CAPA

Root Cause Analysis

Gemba Process / Value Stream Mapping

Contract Review / Quotation / Bid Proposal

Quality Control Plans / ITPs

Data Analysis / Logistics

Risk Estimation / Risk-Based Thinking

Technical Documentation Creation

Laboratory Internal / External Auditing

Continuous Improvement / Kaizen

QA/QC Document / Record Control

International regulation compliance

Supplier Evaluation / Supplier Relations

Health, Safety, Environment / cGMP

Quality Assurance Engineer (1/2020 – 12/2020) - Gilmore Valve, a Proserv Company, Houston, TX

Quality assurance responsibility for a $360M /year and 30,000 square foot manufacturing facility of offshore rig service steel valve design and production

Responsibilities include working directly with a staff of five QC inspectors and directors of all departments to ensure adherence to the QMS and all company quality procedures

Collaborate with international parent organization’s quality systems and compliance initiatives

Participate in the organization’s efforts to obtain API Q1 compliance and certification

Conduct research for future project to achieve AS9100 compliance and certification

Customer property stewardship, coordination, management

Coordinate and conduct all internal QHSE audits and continual improvement efforts by working closely with managers, sales engineers, product engineers, in-house QC testing laboratory, and front-line operators across all divisions

Responsible for ensuring a high level of performance and making major improvements to existing processes, including re-writing existing and creating new SOPs, redeveloping website content, ensuring adherence to updates of all applicable standards, drive down CoPQ, etc.

Perform extensive review of all QMS documents; scale down number of QMS documents to a manageable quantity

Spearhead project to create Quality Review Board monthly to promote awareness of health of the company’s QMS

Collaborate with department heads to drive down CoPQ using data analysis and process improvements

Quality Consultant (12/2016 – 12/2019) - Claire Tessier Quality Consulting, Houston, TX

Provide consulting services to various manufacturing / service organizations for ISO 9001, ISO 17025, ISO 13485, ISO 14971, cGMP (Current Good Manufacturing Practice) compliance / certification

Upgrade all QMS documentation including creating SOPs, work instructions, forms, etc., ensure cGMP adherence

Documentation processing

Nonconforming material handling and disposition

Communicate with suppliers concerning NCRs / CARs generated against them

Supplier site visits / audits

International supplier management

International logistics coordination

HACCP, cGMP, FDA, EPA, TCEQ compliance and auditing

Extensive internal quality / compliance training

Customer-facing presentations

Collaborate with quotation, planning, sales, procurement, third party testing laboratories, engineering departments, as well as shop floor technicians to achieve sales, technical, project management, and quality goals

Quality Assurance Engineer (8/2014 – 11/2016) ValvTechnologies, Houston, TX

Quality assurance responsibility for a $50M / year and 100,000 square foot manufacturing facility, plus international satellite locations in India, UK, and China of high-volume multi-type steel valve design and production

Supervise staff of four QC inspectors and one calibration technician

Coordinate continual improvement efforts by working closely with managers, sales engineers, product engineers, and front-line operators across all divisions, responsible for ensuring a high level of performance

Major improvements to existing processes, including re-writing existing SOPs and creating new SOPs

Contract Manager of high value, complex sales orders involving numerous industry specifications, resulting in elimination of unnecessary waste expenditures of $10 million+ during 2.5 years of employment

Perform extensive MTR and specification review (ASME / ASTM / API, etc.)

Develop and improve web content for public site, create interoffice correspondence as needed, proofread and edit official company correspondences

Interface with project management, engineering, sales, shop floor, machinists, welders, inspectors, suppliers, service department, third party laboratories, and customers to resolve quality issues

Manage comprehensive QA / QMS compliance audits of suppliers to maintain status on approved vendors list or consider for inclusion on probationary status (20+ supplier audits annually)

Manage quality documentation for ISO 9001 certification, verify incoming material documentation and identify non-conforming material, including disposition and SPC / CAPA when deemed necessary for continual improvement efforts

Manage calibration system of 200 instruments, resulting in no audit findings regarding calibration

Manage bi-weekly quality engineering department meetings to enhance QA department’s influence throughout the company, resulting in a reduction in interdepartmental miscommunications

Manage inspection and test plan (ITP) program, documents delivered to customers with every quote and, on more complex projects, requiring extensive modifications to meet customer requirements

Conduct new-hire training on quality concepts (PowerPoint presentation); develop and conduct training of inspection processes for office, outside sales, and shop staff

Create / modify all quality procedures / work instructions and present corresponding training to all departments; reduce number of obsolete / unnecessary documents in the company’s document management system

Manage future transition compliance to ISO 9001:2015 and PED 2014/68/EU

Quality and EHS Engineer (2/2014-7/2014) UTEX Industries, Specialty Valves Division, Tomball, TX

QA / QC and EHS responsibility for a $30M / year and 50,000 square foot manufacturing facility of high-volume specialized steel valve production

Hazardous waste disposal

Supervise staff of three QC inspectors

Overall QMS and EHS program management

Responsible for in-house materials laboratory quality management / calibration

Coordinated waste removal efforts by working closely with managers, supervisors, and vendors, ensuring environmental and safety compliance per government regulations

Quality Consultant (12/2013-2/2014) Fluid Sealing Products, Houston, TX

Develop and implement SOPs and other related documentation in accordance with product specifications and ISO 9001 standard

Processes include high volume production of (10K+ components per day) metal assembly of coated and non-coated fastener and gasket product lines

QHSE Specialist (4/2007-4/2011) Wilson Industries, a Schlumberger Company (DNOW), Houston, TX

Promoted from within the organization with full QMS and supplier evaluation responsibility for company with $2B in annual sales and 500,000 square foot distribution center of PVF and MTS products

Coordinate with team of nine QC inspectors

Coordinate lean transformation efforts by working closely with GMs, managers, supervisors, industrial engineers, third party testing laboratories, and front-line employees across 180+ nationwide branches

Perform extensive internal and external compliance audits

Source and qualify new suppliers to perform QA/QC associated services

Bachelor of Arts with Special Honors -The University of Texas Austin, Awarded 2005

Technical and Computer Skills

Experience in utilization of ASME, API, ASTM, PED, NACE, ISO 9001:2015, etc. standards to ensure compliance

Experience reading and interpreting complex customer provided technical specifications and drawings

Long history of experience with Microsoft Office, SAP/ERP Systems (SAP, Oracle, M2M, IFS, etc.)

Excellent proficiency in English composition, proofreading, grammar checking, spelling, editing, and research

Conversational Spanish

Formal Training

• Procurement and Supply Chain • ASQ Supplier Certification Process

• Internal Auditor ISO 9001, API Q1 • Lean Six Sigma Green Belt Certification

• EPA Toxic Release Inventory • U.S. Customs Audit and Compliance

• Time Management Certification • NASPD Steel Pipe Education Certification

• Continuous Improvement White Belt • TCEQ Hazardous Waste Management

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