Director of Quality Assurance- Minneapolis

Director of Quality Assurance

Company : Neuros Medical

Neuros Medical is a privately held medical device company focused on improving the lives of amputees with chronic post-amputation pain. Their innovative Altius® System, recently approved by the FDA, offers a non-opioid solution for managing this debilitating condition. This patient-controlled device uses electrical nerve stimulation to target and reduce pain signals, leading to significant improvements in quality of life. With a commitment to patient well-being and cutting-edge technology, Neuros Medical is dedicated to providing effective treatments for those suffering from post-amputation pain.

Why You Should Join Us

This is a Director of Quality Assurance role in the Minneapolis area. You will have the opportunity to be responsible for managing all facets of quality assurance, including ownership of the Quality Management System. The primary focus is to ensure that the Quality Management System (QMS) and all aspects of quality assurance are compliant to current and future U.S. FDA, ISO, and MDR Standards and Regulation for Medical Devices, including sterile packaging for products.

As a Director of Quality Assurance , you will :

• Ensure the QMS and design quality requirements are effectively established and maintained in accordance with medical device regulations and international standards
• Be responsible for business processes that ensure conformance of the device with the QMS prior to release and for post-market surveillance
• Manage the Design Quality Engineers as well as oversight and prioritization of departmental tasks and projects
• Develop systems, implement, and train employees on quality and regulatory requirements including, but not limited to, corrective and preventative actions (CAPA), quality audits, post market surveillance and vigilance, and recalls and removals
• Manage systems for design, development, verification, validation, distribution, storage, tracking, post-market surveillance, and retrieval of information pertinent to the design quality processes
• Support product development teams to help meet their objectives
• Oversee quality metrics and quality initiatives, including responsibility for quarterly and annual internal reporting
• Lead and manage post-market surveillance, including device investigations for complaints and field actions
• Develop and facilitate a strategy for a single global quality system and maintains a quality focused culture
• Manages and ensures compliance to training requirements
• Act as the point of contact and lead for all announced and un-announced QMS and product audits from the FDA or authorized regulatory authorities
• Direct the planning and execution of all internal and external audits
• Develop and maintain the quality department budget
• Review and approve document changes for Quality Assurance, as required

What You'll Need

Perks of the Job

Compensation :

Benefits :

Salary : $165,000