Quality Systems Manager
Medical Device Product Development and Manufacturing
Outside Philadelphia PA

Quality Systems Manager - Medical Devices

Global leader in the development and production of life saving medical devices seeks a Quality Systems Manager at the company's flagship site in NE Maryland. The Quality Systems Manager will lead a group of 15-20 with 5 direct reports. The Quality Systems Manager will:

Help develop and maintain quality systems
Ensure compliance with U.S. and foreign regulatory agencies, including ISO 13485 and MDD
Manage the site's document control and change control processes
Provide strategic direction for CAPA program including monitoring, reporting and resolution
Lead the site's audit process including establishing an internal audit program as well as providing leadership for 3rd party audits
Manage the site's Quality Lab
Manage the site's calibration program

Job Requirements

Bachelor's degree in a technical discipline, science or math
7+ years of quality experience in medical devices
3+ years of quality management experience in medical devices
Strong working knowledge of both FDA and international regulations for medical devices
ASQ or CQE certification preferred
Strong leadership and mentoring skills
Strong analytical skills with the ability to prioritize and act decisively
Experience with developing and implementing strategic quality plans

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