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Job Profile
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Top Echelon Network
Quality Engineer
Job Location: Waterbury, CT
5-99 years of experience
Essential Duties and Responsibilities
Provide experienced direction/assistance in developing/implementing additional processes, procedures and controls in an existing ISO9001, ISO13485, and AS9100 registered electronics manufacturing environment in order to comply with ISO, FDA, SAE and other applicable regulatory requirements for the manufacture of commercial, medical, and aerospace electronics.
This position is responsible for the management of MPIs Quality Management System (QMS)
Create, modify, and maintain the existing QMS documentation to ensure total compliance to all regulatory requirements
Provide input into the Management Review process
Develop and implement validation programs, documentation, and reports (IQ,OQ, PQ) in compliance with all relevant regulatory requirements
Perform internal audits to ensure the QMS meets the requirements established by all relevant standards (ISO9001, ISO13485, AS9100, FDA, QSRs, etc.)
Create and utilizes relational databases to collect, analyze, and develop data for measuring compliance with the Quality System requirements for the manufacture of medical electronics
Be the Quality Lean Champion for all Lean events
Work with the Training Department to develop systems and training compliant with all regulatory requirements
Assume the leadership role in driving corrective action and continuous improvement
Chair the Material Review Board (MRB)
Define Quality plans
Act as the Quality liaison in all Technical and Design reviews
Drive supplier corrective action.
Conduct supplier surveys
The above duties may be supplemented occasionally with other job duties and/or assignments related to objectives.
EDUCATION AND EXPERIENCE
Requirements:
Bachelors degree from an accredited college or university.
Five years, minimum, direct experience with ISO9001, ISO13485, and/or AS9100 Quality Systems
Current training/certification as an Internal Auditor (ISO9001, ISO13485, AS9100)
ASQ CQE certification is desirable
Lean experience in a manufacturing environment
Proficient in the use of computer software applications (e-mail, Word, Excel and PowerPoint) as well as quality database applications.
Possess excellent verbal and written communication skills as well as interpersonal skills.
To execute this job successfully, an individual must be able to perform each essential duty satisfactorily.
Be willing to travel up to 10 of the time to customer and supplier sites
Click Here to Apply
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