Sr. Quality Systems Manager

IMRIS; Chaska (MN); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

401(k) savings plus matching

Flexible Spending Account

Life Insurance

Disability Insurance

Vision Insurance

Generous PTO

Incentive bonus

Job summary

IMRIS Imaging, Inc. is seeking a Sr. Quality Systems Manager to develop, implement, and maintain the QMS at our Chaska, MN headquarters.

This role mixes on-site and remote work and oversees CAPA, NCR, audits, training, and compliance with global medical device regulations. The successful candidate will have 7–10 years in medical device quality, a Bachelor’s degree in a related field, and proven leadership experience.

Qualifications

• Bachelor’s degree in engineering or equivalent technical field.
• 7–10 years of quality experience in the medical device industry.
• Experience leading or managing people (3+ years).
• Proven audit leadership for internal and external audits.
• Strong knowledge of 21 CFR 820, ISO 13485 and MDR requirements.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Lead CAPA, NCR, Change Control, and Quality Management Reviews.
• Oversee audit programs and coordinate with stakeholders to ensure compliance.
• Manage training programs and ensure document and record control.
• Supervise the Quality Systems team and drive process improvements.

Skills

Quality Management

CAPA

Audits

Regulatory compliance

Documentation

Process improvement

Education

Bachelor’s degree in engineering or related field

Tools

Arena eQMS

PLM system

MS Office

Job description

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

To date, more than 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.

We are currently searching for a Sr. Quality Systems Manager to join our team. This role will be performed both on-site and remotely, and is based at our company headquarters in Chaska, MN. Please note: there is no relocation offered for this role The ideal candidate will reside in the Greater Twin Cities area.

JOB SUMMARY

The Sr. Quality Systems Manager is responsible for development, implementation, and maintenance of the Quality Management System and is the Quality Management Representative for the IMRIS site(s). The person in this role will develop strategy, policies, processes, standards, and systems that are tailored to evolving QMS requirements as well as the company’s business needs. This role holds direct responsibility for the effectiveness and compliance of key QMS processes, including Nonconformances (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. The Sr. Quality Systems Manager plays a pivotal role in upholding quality standards and process excellence throughout the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Ensure widespread understanding of and adherence to the CAPA program; support CAPA board meetings and drive effective and timely CAPA work product such as action plans, RCA, VOE.
• Utilize collaborative problem solving and partner with process owners, subject matter experts, managers, and other stakeholders as necessary across IMRIS to respond to, and resolve, issues or concerns under the QMS.
• Lead configuration management team and document control functions, including review and processing of change orders, item creation or revision, BOM structures, and ensure stakeholder input is addressed through iterative process improvements.
• Own all aspects of internal and external audits, including scheduling, agendas, internal/external party communications and engagement, front room lead during audits, organize backroom structure, training and SME support to ensure a successful audit workflow.
• Maintain and improve quality management system processes and procedures; ensure training program complies with internal and external requirements and provide ongoing guidance / training to cross-functional team members.
• Engage, lead, and execute training strategies and process improvements with stakeholders across the organization; maintain training program compliance and metrics.
• Lead Quality Management Review meetings, including scheduling, creation of content with stakeholders, and tracking follow-up actions.
• Establishes and maintains departmental quality metrics and escalates adverse trends to supervisor.
• Proactively identify opportunities for improvement based on changing business needs/strategy, evolving QMS trends & requirements; lead and implement actions or efficiency gains where appropriate.
• Guide, advise, or lead change within other QMS processes.
• Supervise the Quality Systems team to guide and facilitate compliance with IMRIS processes and procedures.
• May approve customer site release documents for Quality; provide guidance and training to other Quality members on site release and related processes.
• Conduct or provide oversight for applicable QMS training annually or as needed / for new hires.
• Supervise device history record management and quality records maintenance
• Performs and/or assists non-product software validations
• Manage the Arena eQMS and PLM system for compliance, improvements, and software updates

SUPERVISION RECEIVED AND EXERCISED

• Reports to the VP of Operations, CS and QARA
• This position supervises other employees

KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS

• Demonstrated expertise and experience with 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
• 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
• Foster a positive culture of growth, collaboration and achievement across the organization
• 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
• Experience with internal and supplier audits
• Proficiency with MS Office
• Knowledge of all standards and directives for applicable jurisdictions in the scope of the QMS to include:
• 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)
• CFDA (China) Quality System regulations

IMRIS offers a competitive & comprehensive benefits package that includes:

• Health Insurance
• 401(k) savings plus matching
• Flexible Spending Account
• Life Insurance
• Disability Insurance
• Vision Insurance
• Generous PTO
• Incentive bonus

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. Hiring at the maximum of the range is not typical.

Visit our website: www.imris.com

Visit our youtube channel:

https://www.youtube.com/@imris4993

Follow us on Twitter: @imris_inc

IMRIS is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.