Sr. Quality Engineer

IMRIS Imaging, Inc DBA IMRIS•Chaska, MN

3d•Hybrid

About The Position

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 intraoperative 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 intraoperative 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 intraoperative imaging technologies and shape the future of neurosurgery in operating rooms worldwide. 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.

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

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