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Form of workJob Description
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
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
