Summary: Seeking a Quality Engineer with extensive experience in ISO 13485 and AS9100 Quality assurance within the medical device manufacturing industry.

Requirements:

Bachelor's degree

A minimum of 3 years of progressive ISO 13485 and AS9100 Quality assurance experience

A minimum of 3 years' experience working as a Quality Engineer

A minimum of 3 years' experience working for a medical device manufacturing company

A minimum of 3 years' experience working in a CNC machining/contract manufacturing company

Preferred Skills:

GD & T experience

A minimum of 2 years' experience with CMM programming

Responsibilities:

Implementing and maintaining ISO 13485 and AS9100 Quality system requirements

Developing and fostering a quality system to prevent internal defects from reaching customers

Analyzing failures, corrective, and preventive actions to respond to customer inquiries

Supporting incoming, in-process, and final inspection processes

Managing document control within the Quality Management System (QMS)

Continuously improving Quality inspection work instructions, processes, and procedures

Conducting supplier development, validation, supplier quality audits and ensuring timely resolution of issues

Assisting with continual improvement activities to enhance the quality system using methods such as Kaizen lean methods or similar.

-Conducting internal and supplier audits, CAPA's, SPC, Data Analytics and preparing quality reports.

 

 

 

 

Pay Details: $25.00 to $30.00 per hour

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.