Senior Quality EngineerAs 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 Greater Twin Cities area.Job SummaryThe 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.Essential Duties and ResponsibilitiesAnalyze medical device products for compliance to standardsActively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessedAuthor new SOPs and other documentationReview 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 ManagementWork within a cross-functional team to identify and implement effective controls and support product development from concept through commercializationPerform Design History File audits to investigate and monitor compliance with regulatory requirementsPerforms and leads risk management reviews of traceability matrices to ensure correct linking relationships are established between requirements and Verification/Validation recordsProvides compliance guidance concerning development, application, and maintenance of quality standardsWork directly on Released Product engineering teamsPerform standards analysis and works with engineering on approach to complianceReview verification objective evidence for compliance to standardsWrite design inspection protocols for various productsWrites quality plans to ensure compliance gaps are addressedAssist other functional groups in quality assurance activities and coordinate assigned projects in conjunction with project teamsProvide guidance to other departments on quality requirementsIdentify sources of quality problems and design corrective action programsAssist in the development and/or update of procedures, instructions and methods for inspection, testing, validation/verification, evaluation, recording and reporting quality dataPrepare, support, and ensure the readiness for any potential internal and/or external audits and inspectionsImplements and maintains ISO 14971 Risk Management requirements within procedures and design documentationSupervision Received and ExercisedReports to the Vice President of Operations, QARA, and Customer ServiceThis position does not supervise any other employeesKnowledge, Skills, and Abilities RequirementsCritical thinker and active listener with good time management skillsSelf-starter with the ability to quickly learn about new processes with very little information providedOral and written communication skills, including the ability to write technical reports and presentationsExperience advising senior leadership and applying pre/post market regulationsDirect experience with FDA inspections, MDSAP audits, ISO 13485 audits, and experience communicating with government authoritiesExperience working with remote teams and comfortable being on computer camera during remote meetingsExperience working as main Quality Engineering team member on Released ProductsBachelor of Science (B.S.) degree or higher in engineering and at least 5 years of experience in engineering or QualityKnowledge of ISO 14971 Risk Management standard and state-of-the-art requirementsKnowledge of ISO 62304 Life Cycle Requirements for Medical Device SoftwareKnowledge of Medical Electrical Equipment Safety Standards and other Industry Standards (e.g. IEC 60601-1, 60601-2, IEC 60601-2-33, IEC 62368-1, and NEMA MRI related standards)Ability to read, analyze and interpret engineering/technical drawings, common scientific, technical and quality/regulatory documentsKnowledge of regulations, standards and directives for applicable jurisdictions in scope of the IMRIS QMS to include:European MDD 93/42/EEC and EU MDRCanadian Medical Device Regulations (SOR/98-282)MDSAP (Medical Device Single Audit Program)ISO 13485Japanese QMS Ordinance (MHLW MO 169)Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)US FDA Quality System Regulation, MDR, Recall (21CFR820)CFDA (China) Quality System regulationsIMRIS offers a competitive and comprehensive benefits package that includes:Health insuranceDental insurance401(k) Savings Plan plus matchingFlexible Spending AccountLife InsuranceDisability InsuranceVision InsuranceGenerous paid time off and sick leaveIncentive BonusPaid Parental LeaveCompensation DisclaimerThe actual rate of pay offered within this range may depend on several factors, such as skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer.IMRIS is an equal opportunity employer.
All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.