Robin Merritt

Professional Profile

** ***** ** ************* ******* Assurance experience

Experience in chemical process laboratory management

Experience in Quality Assurance Management

Extensive experience in Chemical 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

Montana Metals Products Quality Engineer (Contract) (11/18 – 2/19)

Responsible for SCAR and customer corrective action, actives determination of RCCA

and project management activities for designated projects

Utilized 6 Sigma Lean techniques and other Quality tools.

Oversaw customer complaint investigation 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 Quality Engineer (Contract) (3/18-5/18)

Preparation of PFMEA for 68 new product introductions

IQ documentation for grandfathered manufacturing equipment which had been previously omitted prior to their introduction in the manufacturing operation.

Dexter Magnetic Technologies Quality Engineer (Contract) (12/16-5/17)

Assisting in preparation for ISO 9100 and, ISO13485 certification attainment

Contracted to assist in audit preparation, gap assessment and claim substantiation for

ISO certifications.

Chicago Magnesium, Aerospace Manufacturer Quality Engineer (6/15 - 8/16)

Responsible for MRB determinations and customer complaint responses,

Responsible for Corrective and preventive measures for non-conforming products.

FMEA, PPAP and risk management experience.

Haemonetics Quality Engineer (Contract) (2014 to 2015)

Verification and validation of design review documentation prior to submittal for 510K medical device approval submission.

Assist in 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.

Hospira Quality Engineer (Contract) (May 2012 - March 2014)

Conducted 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 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.

Served as project manager on select projects.

Pactiv Quality Engineer (Contract) (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.

Novartis Quality Assurance Supervisor (2000-2006)

Supervised associates responsible for Final Device Inspection and disposition of

contact lenses.

Responsible for ensuring compliance to Manufacturing and FDA

guidelines.

Grier Abrasives Manager of Quality Assurance (1998-1999)

Responsible for management of the overall Quality assurance program, including

testing and inspection of raw materials and finished product.

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. 1981 – 1996

Contract Packaging Director (1994-1996)

Oversaw all purchasing, coordination and logistical aspects of all contract-packaging

Responsible for inventory and distribution of finished goods.

Director of Quality Assurance (1991-1994)

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.

Director of Logistics (1992 – 1994)

Oversaw of all major product line new product introductions

Directed concept to launch to distribution.

Quality Assurance Manager (1989-1992)

Responsible for quality in process and final product analysis.

Supervision of chemists and on-line packaging inspectors during processing of formulation batches and packaging of product on filling lines.

Responsible for trouble shooting and endurance to specification for packaged product, and day to day operations 3 shift facility five days a week.

Chemist (1981-1989)

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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