Sr. Quality Engineer

OVERVIEW

As a global leader in intraoperative MRI, IMRIS Imaging, Inc. delivers fully integrated surgical environments that provide clinicians with real-time MRI and imaging insights during procedures. These solutions are designed to improve clinical decision‑making, enhance surgical precision, and ultimately drive better patient outcomes. The IMRIS Surgical Theatre enables seamless intraoperative imaging directly within the operating room, eliminating the need to move patients and ensuring timely access to critical data when it matters most.

To date, more than 70,000 patients have benefited from procedures performed in IMRIS Surgical Theatres worldwide, supporting improved resection rates, reduced reoperation needs, and extended life expectancy in complex neurosurgical cases.

IMRIS continues to advance the field by integrating next‑generation intraoperative imaging technologies and shaping the future of neurosurgery and image‑guided interventions across leading hospitals globally.

We are searching for a Senior Quality Engineer to join our team. This role will be performed on‑site and is based in the While currently a hybrid position, in‑person engagement is required and the ideal candidate should currently reside in the Greater Twin Cities area.

The Senior Quality Engineer is a member of the Quality Assurance team that will directly support medical device product after release. This Senior role is responsible for providing support for design verification and validation activities while ensuring compliance to IMRIS design control procedures, Quality Management Systems procedures, and applicable regulations and external standards.

• Analyze medical device products for compliance to standards
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
• Author new SOPs and other documentation
• Review and approve Change Orders (COs), Nonconformance Report (NCRs) records, Corrective and Preventive Action (CAPA) records, and Deviation Report records. Potential to own quality system NCRs, CAPAs, and project plans relating to Design Assurance and Risk Management
• Work within a cross‑functional team to identify and implement effective controls and support product development from concept through commercialization
• Perform Design History File audits to investigate and monitor compliance with regulatory requirements
• Performs and leads risk management reviews of traceability matrices to ensure correct linking relationships are established between requirements and Verification/Validation records
• Provides compliance guidance concerning development, application, and maintenance of quality standards
• Work directly on Released Product engineering teams
• Perform standards analysis and works with engineering on approach to compliance
• Review verification objective evidence for compliance to standards
• Write design inspection protocols for various products
• Writes quality plans to ensure compliance gaps are addressed
• Assist other functional groups in quality assurance activities and coordinate assigned projects in conjunction with project teams
• Provide guidance to other departments on quality requirements
  
  Identify sources of quality problems and design corrective action programs
• Assist in the development and/or update of procedures, instructions and methods for inspection, testing, validation/verification, evaluation, recording and reporting quality data
• Prepare, support, and ensure the readiness for any potential internal and/or external audits and inspections
• Implements and maintains ISO 14971 Risk Management requirements within procedures and design documentation

• Reports to the Vice President of Operations, QARA, and Customer Service
• This position does not supervise any other employees

• Critical thinker and active listener with good time management skills
• Self‑starter with the ability to quickly learn about new processes with very little information provided
• Oral and written communication skills, including the ability to write…