Quality Assurance Engineer
Resume:
Robin Merritt
********@*********.***
Chicago, Illinois 60619
Qualification for Quality Assurance Management
Professional Profile
** ***** ** ************* ******* Assurance experience Experience in Quality Assurance Management
Extensive experience in Processing and Packaging Quality Assurance Experience in Injection /Blow molding Quality Assurance Experience in Abrasives Formulation and Production Six Sigma Green Belt
Food Sanitization Certificate
ASQ Certified Quality Engineer CQE
Career Highlights
Hydraforce ( contract Actalent)11/8/2022 to June 7th 2024) Supplier quality engineer Responsible for PPAP and ADQPL review and approval . Day to day supplier interaction to improve component Qualitty and supplier performance. Royal Philips ( contract DQE) 1/24/2022 to 7/30/2022 . Remediation project -responsible for design control requirements verification /validation documentation activities. Worked with SME on DHF revisions and modifications. Amgen (US tech solutions)11/23/2020 to 1/20/22. responsible for monitoring supplier
(Flex) for compliance with quality requirements and adherence to standards. Review of DHR documentation and release of product for distribution. Sol-Millennium (Real Staffing Contract)Quality Engineer 04/20-06/20 Responsible for customer complaint responses and working on CAPA resolution in addition to improvement projects.
Montana Metals Products (Belcan) Quality Engineer 11/12 /18– 2/5/19 Responsible for SCAR and customer corrective action, actives determination of RCCA and project management activities for designated projects, utilizing 6 sigma lean techniques and other Quality tools. Responsible for customer complaint investigation and resolution utilizing RCCA methods and SCAR(supplier corrective action request) for customers and suppliers. Utilized lean tools Pareto charts,5 why, 5 s, and other tools in addition to other lean tools in lean manufacturing initiatives. Dexter Magnetic Technologies (Messina Group) Quality Engineer 03/15/2018-05/4/2018 Responsible for preparation of PFMEA for 68 new product introductions and IQ documentation for grandfathered manufacturing equipment which had been previously omitted. prior to their introduction in the manufacturing operation. Dexter Magnetic Technologies (Messina Group) Quality Engineer 12/16/2016-05/26/2017 Responsible for assisting in preparation for ISO 9100 and, ISO13485 certification attainment effort. Contracted to assist in audit preparation, gap assessment and claim substantiation for ISO certifications.
Chicago Magnesium (Aerospace manufacturer) Quality Engineer 6/2015 to 8/2016 Responsible for MRB determinations and customer complaint responses, Responsible for Corrective and preventive measures for non-conforming products. FMEA experience and risk management experience. Experience in PPAP. Aerotek (Haemonetics) Quality Engineer September 15 2014 to March 31st Responsible for verification and validation of design review documentation prior to submittal for 510K medical device approval submission. Temporary position to assist Research and Development in final phase of product development, including design review and transfer activities. Responsible for conducting design reviews and adherence to all design control measures.
Aerotek(Hospira) Quality Engineer May 2012 to March 2014 Responsibilities included conducting change management activities for device products. Worked with cross functional representatives from compliance, regulatory, procurement Marketing, manufacturing and other support related groups for on market product to initiate And execute changes to as deemed necessary to ensure product availability in the marketplace
Responsible for activities from initiation of change to presentation to CCRB. Including verbal and written presentations and reports. I also served as project manager on select projects. Pactiv (Best practice staffing) Quality Engineer (June 2011-December 2011) Performed product testing for injection and extrusion molded cutlery products. Worked on continuous quality improvement projects and prepared customer monthly reports. Responsible for CPK and PPK indices reporting of line performance issues for contract customers. Performed audits to ensure compliance to CFR 21, and customer and company guidelines.
Quality Assurance Consultant- Packaging Inc. (2006-2009) Quality consultant for local entrepreneurial entities commissioned to Create and implement HACCP plans and provide input on crisis management plan for overall management system.
Quality Assurance Supervisor- Novartis (2000-2006) Quality Assurance Shift supervisor at Cibavision of Novartis Supervised associates responsible for Final Device Inspection and disposition of contact lenses. Also responsible for ensuring compliance to Manufacturing and FDA guidelines.
Manager of Quality Assurance at Grier Abrasives (1998-1999) Responsible for management of the overall Quality assurance program, including testing and inspection of raw materials and finished product. Also responsible for analysis of competitor products and formulation of new products. Chicago Vocational High School (CPS) (1997-1998)
Biological Science Instructor
Responsibilities included the instruction of high school students in Biological Science studies. Soft Sheen Products Inc. (1994-1996)
Contract Packaging Director
Responsible for purchasing, coordination and logistical aspects of all contract-packaging Activities, including inventory and distribution of finished goods. Negotiated cost reductions and improved vendor - supplier relations through establishment of a partnership agreements. Director of Quality Assurance – Soft Sheen products (1991-1994) Responsible for overall management of Quality functions, including testing, inspection and record keeping. Planning and managing day-to-day activities of the quality assurance program; new product introduction quality assurance functions including cost constraints and project management. Developed quality assurance policies for new and current products. Managed Quality assurance analytical, microbiological and packaging laboratories. Managed new product launches of Mizzani and New improved Optimum relaxer systems, Body and Shine aerosol, Optimum color projects. Served as an executive committee member on New product and Retail product committees. Reviewed and updated processing and packaging instructions, specifications and guidelines.
Additional Work Experience
Quality Assurance Manager / Chemist – Soft Sheen Products Quality Assurance Manager / BottleWerks, Inc. Plastics/injection –Blow molding, WR Grace, Chicago Confectioneries, and Claire aerosol.
Academic Credentials
Bachelor of Science in Biological Science / Minor in Chemistry – Northern Illinois University Six Sigma Green Belt – Villanova University, 2007
AQS – ISO 9001 Trained Auditor
Food Sanitization Certificate/License
ASQ Certified Quality Engineer CQE
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