Summary:
***Candidates with experience in medical device quality engineering will only be considered***
The individual interacts with all functional levels within the facility while helping to perform the following quality assurance responsibilities: Gage Design, Process Review, APQP , DOE, PPAP and control plan creation and any other inspection responsibilities required by the QA Manager.
Essential Duties and Responsibilities:
Perform calibration duties and program.
Root cause analysis and implementation using tools such as 8-D and 5-Why methodologies
Ability to perform complex Layout Inspections.
Supplier management experience, conduct supplier audits and close out actions
Support the quality inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
Develop inspection instructions and associated documentation to ensure consistent and accurate inspection of products by inspectors and manufacturing personnel.
Apply statistical methodology to analyze test data.
Provide recommendations to the QA Manager regarding measurement techniques to both streamline and improve repeatability and reproducibility of inspections.
Handle special projects assigned by QA Manager and Engineering Department.
Job Requirements:
Minimum
At least five years experience in the Quality Engineering or high level layout inspections, preferably in a metal stamping environment
Good command of ANSI Y 14.5 Geometric Dimensioning and Tolerancing interpretation with practical application for functional gages.
Working knowledge of ISO 9001:2000 and/or ISO/TS 16949:2002 and/or ISO 13485
Must be able to interpret test results, including the clear and effective communication of these results to skilled tool and die makers and engineering personnel.
Excellent communication skills - both written and oral.
Intermediate experience with Microsoft Excel, Word and Access.
Preferred
Training in AIAG manuals APQP, MSA, FMEA, SPC, and PPAP
Experience in programming/operation of RAM Optical 3-Axis Non-Contact CMM
Experience in programming/operation of OGP Smartscope CMM
Experience Gage Design
Certified Quality Technician
