Sr. Quality Systems Manager

IMRIS Imaging, Inc DBA IMRIS•Chaska, MN

24d•$140,000 - $150,000•Hybrid

About The Position

IMRIS Imaging, Inc. is seeking a Sr. Quality Systems Manager to develop, implement, and maintain the Quality Management System (QMS) and serve as the Quality Management Representative for IMRIS site(s). The role develops strategies, policies, processes, standards, and systems aligned with evolving QMS requirements and business needs, and is directly responsible for the effectiveness and compliance of key QMS processes. These include nonconformances, CAPA, Quality Management Reviews, configuration management and change control, training, records control, quality planning, post-market surveillance, deviations, product obsolescence, recalls, supplier management, product inspection, and internal and external audits. The position leads the Quality Systems team and coordinates with process owners, subject matter experts, managers, and other stakeholders across IMRIS to resolve QMS issues and improve processes. Responsibilities also include managing the Arena eQMS and PLM system, supervising device history record and quality records management, and conducting or overseeing applicable QMS training. The role is based at the company headquarters in Chaska, Minnesota, and is performed both on-site and remotely. No relocation is offered; the ideal candidate resides in the Greater Twin Cities area. The position reports to the VP of Operations, QARA, and Customer Service, and supervises other employees.

Requirements

Bachelor’s degree or equivalent technical or engineering experience.
At least 7–10 years of quality experience in the medical device industry.
At least 3 years managing or supervising people.
Demonstrated expertise and experience with a wide array of QMS processes.
Experience supporting audits in front-room and back-room roles and serving as an audit lead.
Experience working with and leading cross-functional teams, including managing organizational change.
Experience with internal and supplier audits.
Knowledge of applicable standards and directives within the QMS scope, including 21 CFR 820 US FDA Quality Management System Regulation, EU MDR, ISO 13485:2016, Canadian Medical Device Regulations (SOR/98-282), Japanese QMS Ordinance (MHLW MO 169), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), and CFDA (China) Quality System regulations.
Proficiency with MS Office.
Excellent organizational skills and attention to detail.
Strong written and oral communication skills.
Strong problem-solving skills, including the ability to manage conflict and guide teams to workable solutions.
Ability to foster a positive culture of growth, collaboration, and achievement across the organization.
The ideal candidate resides in the Greater Twin Cities area.

Responsibilities

Ensure understanding of and adherence to the CAPA program; support CAPA board meetings and drive timely, effective action plans, root-cause analysis, and verification of effectiveness.
Collaborate with process owners, subject matter experts, managers, and other stakeholders to respond to and resolve QMS issues and concerns.
Lead the configuration management team and document control functions, including reviewing and processing change orders, item creation or revision, and bill-of-material structures; address stakeholder input through process improvements.
Own internal and external audits, including scheduling, agendas, communications, audit leadership, backroom organization, and training and subject-matter-expert support.
Maintain and improve QMS processes and procedures, and ensure the training program complies with internal and external requirements.
Lead training strategies and process improvements with stakeholders; maintain training compliance and metrics and provide ongoing guidance and training to cross-functional team members.
Lead Quality Management Review meetings, including scheduling, preparing content with stakeholders, and tracking follow-up actions.
Establish and maintain departmental quality metrics and escalate adverse trends to the supervisor.
Identify improvement opportunities based on business needs, strategy, and evolving QMS trends and requirements; lead and implement actions or efficiency gains where appropriate.
Guide, advise, or lead changes within other QMS processes.
Supervise the Quality Systems team and facilitate compliance with IMRIS processes and procedures.
Approve customer site release documents for Quality when applicable and provide guidance and training to other Quality members on site release and related processes.
Conduct or oversee applicable QMS training annually, as needed, or for new hires.
Supervise device history record management and quality records maintenance.
Perform or assist with non-product software validations.
Manage the Arena eQMS and PLM system for compliance, improvements, and software updates.