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Quality Engineer Medical

Location:
Southaven, MS
Posted:
February 02, 2016

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Resume:

Kerri Frost

**** **** ***** **. ~ Horn Lake, MS *8637

901-***-**** ~ actdd6@r.postjobfree.com

Quality Manager ~ Quality Engineer ~ 5S/Lean 6S Implementation

Summary of Qualifications

Seasoned Quality Professional with more than 14 years of valuable, hands-on experience and a proven track record of implementing best practices and processes in a manufacturing setting.

Outstanding listening, verbal communication and interpersonal skills, building and gaining the trust, confidence and respect of clients, colleagues and others.

Experienced working closely with R&D; medical; regulatory; manufacturing; and customers to complete tasks, including personnel from leading automotive manufacturers.

Self-starter, with a knack for identifying problems and implementing favorable solutions.

Solid Geometic Dimensioning and Tolerancing (GD&T) and mechanical inspection background.

Currently studying to obtain Certified Quality Engineer Certificate.

Certified Mechanical Inspector.

Certified Quality Technician.

Thorough knowledge of a variety of precision measuring devices, and working knowledge of Infinity QS-SPC Software and Minitab.

Areas of Expertise

5S/Lean 6S Implementation Control/Inspection Plans Production Part Approval Process

Six Sigma/Gage R&R Supplier Management Advanced Product Quality Planning

ISO90001-2008 ISO13485 standards 8D Corrective and Preventive Actions

Professional Experience

Quality Engineer, Tegra Medical Jan.2013- Current

Communicated effectively with R&D; medical; regulatory; manufacturing; and customers to complete tasks.

Worked closely with the Operations Department to ensure new products were produced to stated procedures and to the customers’ criteria.

Demonstrated expertise of quality statistical tools; Design of Experiments; Six Sigma; Machine Process Capability Study; Lean Manufacturing; Measurement Systems Analysis (GR&R); and process flows and control.

Collaborated effectively with R&D; medical; regulatory; manufacturing; and customers to complete tasks.

Prepared/updated quality criteria and inspection methods for FAL, In-Process Inspection and Lot Acceptance.

Trained inspectors of best practices of implementation using a variety of procedures and quality tools.

Managed MRB, vendor, internal and customer returns.

Provide valuable, hands-on technical support to CAPA in order to resolve quality issues.

Quality Engineer, PK USA Sept. 2012-Jan. 2013

Work closely with customers and colleagues to complete manufacturing in accordance with 6S lean principles.

Play an integral role with both inspection control plans and process control plans.

Spearhead Advanced Product Quality Planning and Production Part Approval Process submittals.

Professional Experience (continued)

Oversee 8D Corrective and Preventive Actions (CAPA).

Lead Gage Repeatability and Reproducibility (GRR) studies.

Quality Manager, Delta Precision Inc. – Marks, MS Feb. 2012-Sept. 2012

Spearheaded implementation of 5S principles throughout the manufacturing environment.

Built and fostered relationships with the Proto-Type Department and Manufacturing Department.

Managed MRB, vendor, internal and customer returns.

Prepared/updated quality criteria and inspection methods for FAL, In-Process Inspection and Lot Acceptance.

Trained inspectors in implementation of various quality tools and procedures.

Senior Quality Coordinator, RMS Machining – Memphis, TN Apr. 2011-Feb. 2012

Communicated effectively with R&D; medical; regulatory; manufacturing; and customers to complete tasks.

Worked closely with the Operations Department to ensure new products were produced to stated procedures and to the customers’ criteria.

Demonstrated expertise of quality statistical tools; Design of Experiments; Six Sigma; Machine Process Capability Study; Lean Manufacturing; Measurement Systems Analysis (GR&R); and process flows and control.

Quality Engineer/Supervisor of Quality Control, Odyssey Medical Inc. – Bartlett, TN July 2007-Apr. 2011

Collaborated effectively with R&D; medical; regulatory; manufacturing; and customers to complete tasks.

Prepared/updated quality criteria and inspection methods for FAL, In-Process Inspection and Lot Acceptance.

Trained inspectors of best practices of implementation using a variety of procedures and quality tools.

Managed MRB, vendor, internal and customer returns.

Provide valuable, hands-on technical support to CAPA in order to resolve quality issues.

Senior Quality Technician, Paragon Medical – Pierceton, IN Apr. 2004-Nov. 2006

Played a vital role in the implementation of 5S principles across the manufacturing environment.

Performed FAL, in-process and Final inspection of Medical device instrumentation.

Managed customer and internal gauging.

Previously:

Quality Technician, NG Instruments – Warsaw, IN Feb. 2002-Apr. 2004

Quality Technician, Hower Tool – Ossian, IN July 1999-Oct. 2001

Education, Training and Affiliations

Currently studying to obtain Certified Quality Engineer Certificate.

Certified Mechanical Inspector.

Certified Quality Technician.

Member, American Society for Quality.



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