Quality Engineer

Amy Otteson Crichfield

***********@*****.***

*** *. ***** ** #*** Mesa, AZ 85201 602-***-****

SUMMARY

Biomedical Engineer with 2 years of experience in the medical device industry. Hardworking professional with proven ability to reduce conflict between coworkers. Analytical problem solver who values challenging tasks and assignments. Lean Leader Trained and Statistics for Manufacturing Certification acquired.

WORK EXPERIENCE

The Tech Group – Tempe, AZ Medical Device Manufacturer

Quality Engineer II

Responsible for ensuring medical device documentation is correct and meets guidelines and regulations. 07/08 – 06/10

• Initiate appropriate quality controls, control plans, process testing, and corrective action as needed to ensure product and process integrity.

• Refine quality plans and systems and create statistically based sampling plans for routine medical device manufacturing.

• Statistics for Manufacturing. Course included statistical means of approaching issues with quality (DOE, SPC, GR&R, Cpk).

• Review all metrology data including Statistical Process Control Data and investigate any discrepancies or errors.

• Create and modify Work Instructions to be used by production staff.

• Utilize knowledge of FDA regulations (21 CFR Parts 11, 210, 211, and 820) and ISO Standards (9001 and 13485).

• Analyze and interpret findings from capability studies and engineering studies to determine mold qualification.

• Ensure molding and assembly validation (IQ, OQ, PQ) documentation meets customer, FDA, and internal requirements.

• Author validation protocols and reports for IQ/OQ of visual measurement machine as Subject Matter Expert.

• Lean Champion. Course included Six Sigma lean initiatives to reduce quality defects.

• Initiate, investigate, and aid in disposition of Non-Conformance Reports for molding and assembly issues. Assist with CAPAs when necessary.

SKILLS

Experience using:

o Word – 10 years

o PowerPoint – 8 years

o Excel – 5 years

o Mathcad – 1 year

o Outlook – 1 year

o P-Spice – 6 months

o C++ – 6 months

o Minitab – 6 months

o Solid Works – 3 months

EDUCATION

Arizona State University, Tempe, AZ 8/04 – 5/08

B.S.E. Biomedical Engineering, with emphasis on biomaterials – Graduated Cum Laude May 8, 2008

• Dean’s Honor List – Fall 2004 – 2007, Spring 2006 • GPA: 3.56/4.0

• Senior Capstone Design Project: Drug Coating for the Inside of a Shunt

Skills utilized include:

• Succeeding individually on project tasks and contributing ideas in group design sessions

• Quickly learning tasks necessary for project completion and maintaining motivation and enthusiasm for the project • Applying exceptional writing skills for detailed reports each week

• Conducting successful presentations of product design

• Analyzing and solving problems that occurred during the design process

• Successfully meeting all report and project deadlines on time or early

• Prioritizing and organizing all assignments with meticulous attention to detail

Everest University, Online 11/10 – Current

• Degree Pursuing: M.B.A. • GPA: 3.0/4.0

Contact this candidate