Need - Supplier Quality Engineer

Hi,

The following requirement is open with our client.

Title : Supplier Quality Engineer

Location : Warsaw, IN (ONSITE)

Duration : 12 Months

In-Person Interview : No

Relevant Experience (in Yrs.) : 8

Detailed Job Description:

• Experience in Supplier Production Parts Approval (SPPA) process.
• knowledge of basic quality tools, risk analysis, statistics (SPC), and inspection techniques.
• Ability to read and understand engineering drawings.
• Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ.
• Specific experience with Test method Validation and Gage R&R.
• Experience with root cause analysis and problem-solving for both technical and process issues.
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003.
• Good problem-solving skills through the use of quality and statistical tools.
• Ability to read and understand engineering drawings.
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis.
• Knowledge of Quality System requirements, ISO and FDA requirements.
• Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts.
• Microsoft Office Suite and Project