Quality Technician

Gage R and R studies experience is REQUIRED for this position

Provide acceptable product for use by inspecting and testing product at various stages of the process (i.e., incoming, subassembly, in-process, QA test, Final QA)

Provide correct and accurate Quality records by reviewing documentation and ensuring that requirements have been met

Support supplier monitoring by performing First Article Inspections and Supplier Correlations

Document Non-conforming Product by generating Defect Reports

Support trending of various Quality metrics by generating
Pareto charts of various Quality metrics

Track material in MRP system, by performing transactions

Provide product traceability and other required documentation by maintaining QA files (i.e. specifications, batch filing, history records, etc.)

Monitor environmental clean room by performing particle counts

Control non-conforming product by identifying and segregating product

Disposition product and/or inventory as directed by following directions on Defect Reports and/or released Engineering Change Notices

Perform daily equipment calibration

Support continuous improvement efforts by suggesting or recommending changes/improvements

Support Quality improvement initiatives by conducting Test Method Qualifications and Gage R and R studies
REQUIREMENTS
EDUCATION/EXPERIENCE
High School Diploma or GED

1-3 years inspection and test experience of mechanical and electronic components, sub-assemblies and final assemblies

Experience with ISO9001:2000 or ISO13485:2003 Quality Systems, preferably in the Medical Device industry

Experience with Inspection, Test and Measurement equipment to verify product conformance to specifications and standards

Ability to read and understand drawings, Bills of Material and Standard Operating Procedures

Familiar with Microsoft Excel and Access

ASQ certification as a CQT or CMI preferred but not required