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Quality System Manager

Location: Headquarters
Job Code: 1324
# of openings: 1

Description

As the Quality System Manager, you will develop, maintain and manage the quality system in compliance with ISO 13485 and QSR820.  You will engage with managers and employees to ensure quality is a primary focus in all aspects of business operations.

 Responsibilities:         
Maintain the quality system in compliance with ISO 13485 and QSR 820
Manage Corrective Action and Preventive Action programs; make sure the CA/PA system is actively being used with results analyzed for effectiveness
Manage the calibration and preventive maintenance programs
Perform internal audits and develop team to perform audits
Assist with regulatory, customer, and registration audits
Oversee the complaints management process
Perform, and participate in supplier qualification audits.  Work with the supply chain organization to ensure supplier performance meets our quality and strategic requirements
Oversee the training program
Ensure Quality objectives are measured and reviewed to ensure effectiveness
Prepare data and coordinate management reviews

 Position Requirements:         
M.S. degree in an engineering or in a scientific field
5 to 8 years of relevant experience working with medical device and/or in-vitro diagnostic.
In depth experience with ISO 13485 and QSR 820 for in vitro diagnostic
Practical experience with ISO 14971, IEC 62304, and IEC 62366
Experience managing CA/PA program
Experience building quality system from the ground up
Excellent communication skills with strong attention to details and ability to multi-task
Experience working with cross-functional teams
Practical experience with lean principles
Willingness to be hands-on with solid problem solving skills
ASQ certification preferred






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