Senior Quality Systems Manager

IMRIS

. Develop, implement, and maintain the Quality Management System .

Posted 10/16/2026full-timeChaska • Minnesota • United StatesSenior💰 $140,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Management Systems (QMS) within the medical device industry, including compliance with regulatory standards such as ISO 13485:2016 and 21 CFR 820. Proven ability to lead cross-functional teams, manage audits, and implement process improvements effectively.

Highest-signal resume keywords

Quality Management System DevelopmentInternal And External AuditsRegulatory Compliance KnowledgeTeam Leadership And SupervisionCAPA Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System ProcessesRoot Cause AnalysisChange ControlDocument ControlTraining ComplianceQuality PlanningPost Market SurveillanceSupplier ManagementNon-Product Software ValidationMetrics Establishment

Soft Skills

Strong Problem-Solving SkillsExcellent Organizational SkillsStrong Written And Oral Communication SkillsConflict ManagementTeam Guidance

Tools & Technologies

Arena eQMSPLM SystemMS Office

Industry Keywords

Medical Device Industry21 CFR 820ISO 13485:2016EU MDRCanadian Medical Device RegulationsJapanese QMS OrdinanceAustralian Therapeutic Goods RegulationsCFDA Quality System Regulations

About the role

Key responsibilities & impact

Develop, implement, and maintain the Quality Management System
Serve as Quality Management Representative for IMRIS site(s)
Develop QMS strategy, policies, processes, standards, and systems
Own and ensure effectiveness and compliance of QMS processes including NCR, 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/External audits
Support CAPA board meetings and drive timely CAPA work products, including action plans, root cause analysis, and verification of effectiveness
Partner with process owners, subject matter experts, managers, and stakeholders to resolve QMS issues
Lead configuration management and document control functions, including change orders, item creation or revision, and BOM structures
Own internal and external audits, including scheduling, communications, audit-room leadership, back-room organization, training, and SME support
Maintain and improve QMS processes and procedures
Lead training strategies, process improvements, training compliance, and metrics
Lead Quality Management Review meetings and track follow-up actions
Establish departmental quality metrics and escalate adverse trends
Identify and implement QMS improvements and efficiency gains
Guide, advise, or lead change within QMS processes
Supervise the Quality Systems team
Approve or provide guidance on customer site release documents
Conduct or oversee QMS training for existing employees and 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
Report to the VP of Operations, QARA, and Customer Service

Requirements

What you’ll need

Bachelor’s degree required or equivalent technical/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
Front-room and back-room audit support, and audit lead experience
Experience working and leading cross-functional teams
Experience managing change within an organization
Experience with internal and supplier audits
Excellent organizational skills and attention to detail
Strong written and oral communication skills
Strong problem-solving skills, ability to manage conflict and guide teams to workable solutions
Proficiency with MS Office
Knowledge of 21 CFR 820 US FDA Quality Management System Regulation
Knowledge of EU MDR
Knowledge of ISO 13485:2016
Knowledge of Canadian Medical Device Regulations (SOR/98-282)
Knowledge of Japanese QMS Ordinance (MHLW MO 169)
Knowledge of Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
Knowledge of CFDA (China) Quality System regulations

Benefits

Comp & perks

Health Insurance
Dental Insurance
401(k) savings plus matching
Flexible Spending Account
Life Insurance
Disability Insurance
Vision Insurance
Generous PTO
Incentive bonus
Paid Parental Leave