Quality Engineer Ii Jobs

Careers that Change Lives
Part of the Neuroscience portfolio, Cranial and Spinal Technologies is comprised of four global businesses: Spine & Biologics, Enabling Technologies, and China Cranial, Spinal, Orthopedics & Technologies.

• Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion.
• China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics.
• Enabling Technologies, delivers an innovative portfolio which include robotics, navigation, intra-operative imaging, advanced energy devices, cerebral spinal fluid management and critical care.

Join a Culture of Collaboration and Innovation.
A Day in the Life
 
In this exciting role as a Quality Engineer II you will support post market quality activity including risk evaluations, product trending and signal evaluation, complaint investigations, and surveillance reporting for the Cranial and Spinal Technologies (CST) operating unit.  This role will primarily support post market surveillance activity for Medtronic’s intelligent data solutions (iDS) business, but provides exposure and opportunity across the CST operating unit. 
ESSENTIAL FUNCTIONS:

• US and International travel requirement: Less than 10%
• All other duties as assigned.
• Collaborate with cross-site Post Market Quality, Regulatory Affairs, and Engineering to support and author pre- and post-market product risk assessments.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Define and maintain statistical thresholds for complaint monitoring. Execute post market trending process.
• Provide support in completing returned product analysis and investigation.
• Provide support for Corrective and Preventive Actions (CAPA).
• Supports business initiatives for process improvement.
• Provide quality engineering support or process ownership for global post market surveillance processes specifically focusing in the areas of product investigations, complaint investigations, escalated issue investigations, and post market surveillance plans and reports.
• Ensure post market surveillance processes maintain regulatory compliance including supporting MDR, MDD, and EUMDR required activities for post market surveillance.