Sr. Quality Engineer

Overview

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

Essential Duties and Responsibilities

• Analyze medical device products for compliance to standards
• Participate in the Design Change process to ensure proposed changes are thoroughly analyzed and assessed
• Author new Standard Operating Procedures (SOPs) and other documentation
• Review and approve Change Orders (COs), Nonconformance Reports (NCRs), Corrective and Preventive Action (CAPA) records, and Deviation Report records
• 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
• Perform and lead risk management reviews of traceability matrices to ensure correct linking relationships are established between requirements and Verification/Validation records
• Provide compliance guidance concerning development, application, and maintenance of quality standards
• Perform standards analysis and work with engineering on approach to compliance
• 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
• Aid 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
• Implement and maintain ISO 14971 Risk Management requirements within procedures and design documentation

Supervision Received and Exercised

This position reports to the Director of QA. This role does not supervise any other employees.

Knowledge, Skills, and Abilities Required

• 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 and comfortable being on computer camera during remote meetings
• Experience working as main Quality Engineering team member on Released Products
• Bachelor of Science (B.S.) degree or higher in engineering and at least 5 years of experience in engineering or Quality
• Knowledge of ISO 14971 Risk Management standard and state-of-the-art requirements
• Knowledge of ISO 62304 Life Cycle Requirements for Medical Device Software
• Knowledge 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 documents
• Knowledge of regulations, standards, and directives for applicable jurisdictions in scope of the IMRIS QMS to include: European MDD 93/42/EEC and EU MDR, Canadian Medical Device Regulations (SOR/98-282), MDSAP (Medical Device Single Audit Program), ISO 13485, Japanese 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 regulations

Benefits

• Health insurance
• Dental insurance
• 401(k) Savings Plan plus matching
• Flexible Spending Account
• Life Insurance
• Disability Insurance
• Vision Insurance
• Generous paid time off and sick leave
• Incentive Bonus
• Paid Parental Leave

Compensation

The 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.

Contact Information

Visit our website: www.imris.com

Visit our youtube channel: youtube.com/user/imris_inc

Follow us on Twitter: @imris_inc