Sr. Quality Engineer

As a leader in image guidance solutions, IMRIS Imaging, Inc. provides optimized, fully integrated image‑guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Surgical Theatre enables intra‑operative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils, and OR tables for use in this unique and multifunctional intra‑operative environment.

It is estimated that over 70,000 patients have benefited from lifesaving or life‑extending procedures performed in an IMRIS Surgical Theatre. IMRIS will continue to integrate new intra‑operative imaging technologies and shape the future of neurosurgery in operating rooms worldwide.

The Senior Quality Engineer will work on‑site as a hybrid position that requires in‑person engagement. The ideal candidate should currently reside in the Greater Twin Cities area. This role is a member of the Quality Assurance team that will directly support medical device product after release. The 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.

$/yr - $/yr

• Annual Bonus

• Analyze medical device products for compliance to standards
• Actively participate in the Design Change process to ensure the proposed changes to the products are systematically 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
• 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 Director of QA
• 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 technical reports and presentations
• Experience advising senior leadership and applying pre/post market regulations
• Direct experience with FDA inspections, MDSAP audits, ISO 13485 audits, and experience communicating with government authorities
• Experience working with remote teams…