Quality Engineer - Entegee

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.