Quality Engineer Product

Marina L. Gray

Phone: 704-***-****

E-mail: ***********@*****.***

WORK HISTORY:

Quality Engineer, HYDAC Technology Corporation/ Denver, NC / 2024-Present

•Providing engineering support to operations ensuring consistent application of quality techniques.

•Resolving quality issues of capability, tolerancing, and materials related issues.

•Resolving quality issues by identifying problems, examining solution options, implementing action plans, and providing resources.

•Develop and submit PPAP (Production Part Approval Process) documents for new product launches to meet customer requirements.

•Determining when process stability and capability studies should be performed on existing processes. Review and analyze results. Recommend changes to processes based upon findings and perform follow up to verify effectiveness.

•Participating in the Advanced Product Quality Planning activities to determine appropriate use of existing and new measurement systems during new tool or process design and startup.

•Participating in the development of Failure Mode and Effects Analysis (FEMA).

•Facilitating and promoting use of appropriate problem-solving techniques for effective root cause analysis and successful corrective action.

•Coordinating with Sales, Purchasing, Engineering, and Production to resolve customer complaints and concerns.

•Leading PPM improvement plan for strategic customers; execute and assist with ISO Audit plans; manage Document Control system; Managing quality department projects.

•Responsible for customer, supplier and internal corrective actions.

•Supporting quality KPI (Key Performance Indicator) development and reporting, coordinate data analysis and reporting.

•Responsible for the raw and in process materials internal or external testing quotes and capability.

Quality Assurance Specialist, Mitsubishi Materials USA/ Mooresville, NC / 2022-2024

•Prevented mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers, which is part of quality management focused on providing confidence that quality requirements.

•Responsible for executing, maintain & updating procedures / tasks related to Product Quality complaints investigation processing, Customers concerns on any quality aspect, Quality audits of our Local USA suppliers, interaction on quality and inspection process with our master vendors (RFM/MTA) as well as primary supply plants at MMC.

• Responsible for product quality compliance, and other operational compliance documents from MMC and local partners is involved.

•Handled all issues of quality complaints, product recall, and their resolution after root cause findings with suppliers and with sales/logistics/customers in a timely manner is imperative in this role.

•Responsible for data recording, maintaining records, analysis of investigation findings /report, and follow-thru with sales to customer satisfaction on quality matters is essential. Regular reporting and reviews of quality & compliance status to management is part of the routine tasks.

•Complaint and Investigation (CR/IR) request handing (Standard & Special products), ISO (International Organization for Standardization) certification request, and support on any related required information. Audit request by customers (Paper and Field).

•Environmental certification request (ROHS (Restriction of Hazardous Substances), REACH (registration, evaluation, authorization and restriction of chemicals), Proposition 65 and any others). Export control certification request (EAR (Export Administration Regulations), ITAR (International Traffic in Arms Regulations), Conflict Minerals and many others). Local suppliers set up. Audit to local suppliers including management of supplier’s approval drawings.

Support Services Supervisor, Element Materials Technologies / Charlotte, NC / 2021-2022

•Ensured that all planning process are providing an optimum customer service level and working capital performance as defined by the organization’s business operating plans and strategic objectives. Monitored output/results while providing feedback and adjusting process to continuously improve.

•Accomplished day-to-day work operations by initiating, coordinating, and enforcing order entry policies and procedures. Managed the order entry and certification team. Improved data entry quality results by completing audits; identifying trends; determining system improvements; studying, evaluating, and re-designing work processes; implementing changes.

•Facilitated ITAR/EAR documentation, proficient with the quality reports and internal and external requirements, developing or updating procedures and quality documentation.

•Served as the point of contact for issue-escalation between the labs, sales, and order entry and certification department. Created all purchase orders for the support services group using Dynamics AX software. Facilitated new vendor setups and establishing payment terms.

Powder lab technician, Oerlikon AM / Huntersville, NC / 2017-2021

•Performed metal alloy materials, powders, and printed coupons testing, supported R&D and QC departments; responsible for management of the laboratory workflow, operating, calibrating and maintenance of the analytical and other laboratory equipment, writing work instructions and SOPs; training new technicians, providing reports and managing the data, communicating with vendors, purchasing supplies and general supervision of the laboratory.

•Responsible for providing and overseeing materials analysis, administration of the laboratory services, testing policies and practices, oversee broad areas of operations such as testing, scheduling, inventories and coordination of the lab services, providing the research, feedback and decisions to resolve complex internal and external customers questions, ensure accuracy of the tests and operational databases, reports, and related details through the audits and operational reviews, overseeing and reviewing, completing and processing broad degrees of tests, forms, documents, databases and related materials and information, providing analysis and interpretation regarding tested materials, give feedback regarding the operations and leading to the implementations and change, promoting and supporting overall mission.

QC lab supervisor, R&D project technician, IDFL / Salt Lake City, UT / 2014-2017

•Completed proactive maintenance and repair actions to keep equipment operating at peak levels. Maintained system logs or manuals to document testing or operation of equipment. Inspected systems, diagnosed problems, and developed optimal solutions. Procured parts and maintained inventory and related documentation.

•Educated equipment operators on proper use of equipment. Created spreadsheets using Microsoft Excel for daily, weekly, and monthly reporting. Completed all paperwork, recognizing any discrepancies and addressing them in a timely fashion.

QC laboratory technician, Hexcel Corporation / Salt Lake City, UT / 2014-2014

•Prepared carbon fiber materials for tensile testing: cut, plied, laid up carbon fiber sheets, cured in autoclave. Tested carbon fiber materials, operated Instron system, prepared documentation according to SOPs. Evaluated samples against standards by completing measurements, visual inspections and other established tests. Inspected manufactured parts by reviewing visually and assessing dimensions.

•Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes. Determined root cause of deviations and non-conforming results and implemented appropriate corrective and preventive actions throughout product development process. Performed thorough inspections of incoming materials and outgoing products. Set and oversaw quality assurance guidelines for laboratory work.

Laboratory technician, IDFL / Salt Lake City, UT / 2013-2014

•Prepared down and feather samples for a multiple physical and chemical test, used laboratory equipment such as ovens, shakers, and variety of lab wear, performed pH, oxygen, turbidity tests. Verified cleanliness of organic and non-organic fills, performed moisture and fat/oil tests (saponification of organic and non-organic components), researched polymer chemical testing, reviewed and created new laboratory test methods.

•Kept laboratory in compliance with all applicable guidelines and laws. Oversaw items in inventory and reordered before supplies diminished. Tracked collected specimens and noted times of collection.

QC Laboratory technician, Biomerics LLC / Salt Lake City, UT / 2012-2013

•Visually inspected catheters, performed conditioning, tensile and burst physical tests, applied melting techniques. Performed quality control of the polymer solutions and coating solutions for the catheters using viscometer, pH meters, UV-vis, received chemicals and determined quality using FTIR. Inspected amount of chlorhexidine acetate in catheters coating: conditioned, extracted, applied dilution/elution and tested samples according to SOPs.

•Prepared samples and standards, operated HPLC, prepared samples for GC, performed contact angle tests for the catheters. Evaluated samples against standards by completing measurements, visual inspections, and other established tests.

•Generated detailed reports outlining results and recommendations. Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes. Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements. Set and oversaw quality assurance guidelines for laboratory work.

EDUCATION:

•2023-Present MS Material Science and Engineering-North Carolina State University, Raleigh, NC

•2010-2013 BS Biotechnology Laboratory Technician-Utah Valley University, Orem, UT

•2010-2013 Applied Forensic Science -Utah Valley University, Orem, UT

•2006-2010 AAS Biotechnology Laboratory Technician-Salt Lake Community College

CERTIFICATES AND DIPLOMAS:

•6 Sigma training, June 2022

•ICP-EOS, Avio 500 operator certificate, July 2019

•LECO CS844 operator certificate, June 2018

•Internship InnovaBio, SLCC, 2013

•Internship Unified Police Department of Greater Salt Lake Crime Lab, 2013

•Certificate of Attendance 16th National CODIS Conference (Presentations on DNA related areas, such as Audit, CODIS, DNA Analysis, Legal Topics, QA), 2010

•Certificate of Training Advanced Level 1,2 DNA course - Sorenson Forensics, May 18-19,2009

•Basic Applied Forensic Science and Crime Analysis Certificate-CSULB, Fall, 2008

•High School Diploma, 1995

TECHNICAL SKILLS:

•PPAP, Internal and External Audits.

•Welding prep process and advanced welding techniques training.

•SolidWorks Inspection 2022

•MSE500 Modern Concepts of Material Science; MSE540 Processing of Metallic Materials; MSE580 Materials Forensics and Degradation; MSE591 Special Topic Quantitative Materials Characteristics (Advanced Microscopy)

•Operating and performing maintenance on equipment such as LECO CS844, LECO ONH836, FT4 powder rheometer, Microtrac particle size analyzer, Accupyc 1340 Pycnometer gas displacement density measurement, moisture analyzer HX204, Revolution Avalanche powder flowability and energy analysis, Malvern G4 particle morphology analysis, ICP-EOS Avio500.

•Operation, maintenance and troubleshooting analytical instrumentation HPLC, GC, NIR, RI, FTIR, LC, TLC, UV-Vis, MS, Titrator, Kruss and Instron systems.

•Knowledge of quality reports, proficiency in Round Robin testing, document control, method development and validation, development of SOPs according to ASTM and customer standards, technical writing, strong computer proficiency such as email, Microsoft Office, SAP, ASANA, LIMS, Labman and operation of listed instruments software.

•Knowledge of the sample and standards preparation, analysis of organic and non-organic materials, receiving and quality control of raw chemicals, quality control of in-process production materials and finished products, facilitating calibration of test and measuring equipment and performing process audits.

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