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Experience the excitement of working in a growing and innovative company. Sentinelle is home to dedicated people committed to developing leading edge MRI products and software.
We thank you for your interest, but only those applicants selected for an interview will be contacted.
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Quality System Leader
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Reporting to the VP Manufacturing, the Quality System Leader will lead development of world class processes in a high-tech, innovative environment. The successful candidate will lead improvements in a fast-paced company that incorporates engineering, applications training, sales, service and manufacturing activities under one roof.
Responsibilities
The Quality System Leader will:
· Develop processes and controls of critical functions across the entire range of company functions.
· Ensure up-to-date regulatory compliance of medical devices in multiple jurisdictions
· Gather data and rapidly identify trends and risks; develop and lead remedial action where problems arise.
· Facilitate cutting-edge product development & test methodologies with a high level of user feedback throughout the lifecycle
· Fine tune and execute internal audit plan to suit unique needs of the organization.
· Provide input into new designs to ensure regulatory compliance.
· Work with large vendors and testing houses to interpret product requirements.
· Ensure environmental stewardship standards are upheld (RoHS, WEEE standards, etc).
· Lead quality oriented projects and initiatives
Required
· Minimum 3 years management experience in an engineering and manufacturing environment.
· Experience with hardware and software-based medical devices.
· Experience managing an ISO 13485/FDA GMP quality system.
· ISO 14969 training.
Preferred
· In addition to Quality background, an engineering, scientific or technical background is an asset.
· Experience in management of small to medium-sized growth organizations
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