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. JOB SUMMARY 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. ESSENTIAL DUTIES AND RESPONSIBILITIES • 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 SUPERVISION RECEIVED AND EXERCISED • Reports to the Vice President of Operations, QARA, and Customer Service • This position does not supervise any other employees KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS • 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 IMRIS offers a competitive and comprehensive benefits package that includes: • 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 Disclaimer 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. Visit our website: www.imris.com Visit our youtube channel: http://www.youtube.com/user/imrisinc