Quality Engineer Product Development

Experienced and reliable quality engineer with ** years’ experience

managing quality and working collaboratively in ISO environments.

Key Qualifications

Experience as a Quality Professional

oASQ Certified Quality Engineer (Recertification in progress, est. completion June, 2016)

o30 years of experience as quality professional in Supply, Product Development, and Reliability

o22 years of experience in an ISO 9001 high volume manufacturing environment

o8 years of experience in an ISO 13485 Medical Manufacturing and Assembly Environment

oManaged medium to large projects: $100k - $500k

oCreated and supported product validation protocols

oSix Sigma Green Belt Certified

oExperience with MiniTab, Epicore ERP, DataLyzer and QC-Calc/Prolink

Skilled communicator and collaborator

oReputation as an excellent problem solver with my colleagues

oExcellent writing and verbal communication skills

oAbility to communicate new ideas to others in easy to understand fashion

Extensive analytical and technical experience

oSubject matter expert in GD&T and blueprint reading

oExtensive experience using and interpreting SPC charts and SPC software

oAbility to analyze data to create Cpk, Ppk, GR&R, and detect trends and non-conformities

oDevelop product quality plans in a short cycle development job shop environment

oConduct root cause analysis for CAPA activities

Relevant Skills and Experience

Quality Management

Performed internal audits to assure compliance with internal standards and customer requirements

Hired and directed multiple quality technicians;

oHelped technicians prioritize daily tasks for most effective use of time

oDirected and coached technicians in writing inspection procedures and work instructions

oCoached technicians in performing data analysis

oPerformed performance reviews and recommended suitable individuals for promotion

Prepared reports on cost of quality indicators to assist in process improvement prioritization

Utilized Microsoft Office Suite, including Microsoft Project to track, manage, and report on quality metrics.

Worked cooperatively to reduce system non-conformances every quarter through CAPA activities

Initiated and supported SCAR activities to improve supplier performance issues and resolve non-conforming events

System Development

Made recommendations and implemented improvements to Non-conformance System by adding metrics and creating log for tracking and reporting to weekly management meetings

oReduced time to completion of open non-conformances from an average of 30 days to 4 days

Implemented an automated data collection application that allowed manufacturing, engineering, and quality, to see real time manufacturing data and SPC charts

oReduced scrap, rework, and sorting by 10%

oCentralized database for manufacturing data reduced data preparation and certification for shipment by 70%

oReduced engineering response time

Designed and implemented APQP in conformance with ISO 13485 and ISO 9001

Documented a functional specification for bar code application

Customer Relationships

Worked collaboratively to bring 10 to 15 programs through the APQP development process

oInitial phases: Understand and document customers’ requirements and determine how best meet these needs while conforming to the Quality System

oMiddle phases: Documented Quality Plans, conduct PFMEAs, and generate and oversee execution of, and write reports of validation protocols

oLater phases: Maintained and improved process capability and control using statistical methods

Collaborated with customers to resolve non-conformance events related to product and quality system

Used statistics to characterize outgoing quality levels to track quality trends

Supplier Relationships

Worked with suppliers during product development to “flow down” customer requirements

oInitial phases: Conducted suppler audits to assess willingness and capabilities to conform to necessary requirements and assisted suppliers being placed on approved supplier list

oMiddle phases: Established and wrote product and raw material inspection plans, assisted suppliers in achieving acceptable first articles, and approving validation protocols

oLater phases: Maintained conformance to established requirements through supplier performance assessments and reported results to suppliers

Worked collaboratively with manufacturing engineers to resolve non-conforming conditions, and improve process capabilities

Led Material Review Board for incoming nonconforming material

Project Work

Gathered requirements for new software projects

Coordinated testing and implementation of new software applications

Employment History

Quality Engineer September 2007 – September 2015

Metro Mold and Design Rogers & Brooklyn Park, Minnesota

Metro Mold and Design is a medical molding and assembly contract manufacturer supplying global medical companies.

Responsible for all aspects of quality control process including managing customers, incoming quality control, ongoing quality control, product development, quality plans and nonconformance resolution

Product Quality Engineer

Reliability Engineer

Development Quality Engineer

Quality Technician August 1985 – June 2007

Hutchinson Technology, Inc. Hutchinson, Minnesota

A world-leading high volume manufacturer of critical precision micro electromechanical components serving the hard disk drive industry

Responsible for all aspects of quality control

Education

Associate Degree, Drafting and Design Technology

Willmar Technical College Willmar, Minnesota

Additional coursework

Reliability Engineering & Software Quality Engineering, ASQ

Statistics & Applied Linear Statistical Models, St. Cloud State University

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