Senior Quality Systems Leader — Medical Devices & CAPA Mastery

IMRIS Imaging, Inc DBA IMRIS; Chaska (MN); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

401(k) matching

Flexible Spending Account

Life Insurance

Disability Insurance

Vision Insurance

Generous PTO

Incentive bonus

Paid Parental Leave

Job summary

IMRIS Imaging, Inc DBA IMRIS seeks a Sr. Quality Systems Manager to develop, implement and maintain the QMS across IMRIS sites. You will drive CAPA, audits, training and process improvements to ensure compliance with global standards and customer requirements.

The role combines on-site leadership at our Chaska, MN headquarters with remote work flexibility, reporting to the VP of Operations, QARA, and Customer Service. A strong background in medical device quality is essential.

Qualifications

• Experience with a broad set of QMS processes.
• Front- and back-room audit support and audit lead experience.
• Experience leading cross-functional teams and managing change.
• 7–10 years quality experience in the medical device industry
• 3+ years managing or supervising people
• Bachelor’s degree or equivalent engineering experience
• Familiar with 21 CFR 820, ISO 13485 and related standards.

Responsibilities

• Develop and maintain the Quality Management System (QMS).
• Serve as Quality Management Representative for IMRIS sites.
• Lead CAPA, NCR, and internal/external audits.
• Oversee training programs and cross-functional guidance.
• Manage document control and change control processes.
• Supervise the Quality Systems team and provide guidance.
• Ensure regulatory compliance and quality performance metrics.
• Coordinate supplier management and product inspections.

Skills

QMS processes

Audit lead

Cross-functional

Change management

Regulatory knowledge

Documentation

MS Office

Training & coaching

Quality metrics

Education

Bachelor’s degree or equivalent engineering experience

Tools

Arena eQMS

PLM system

MS Office

Job description

IMRIS Imaging, Inc DBA IMRIS seeks a Sr. Quality Systems Manager to develop, implement and maintain the QMS across IMRIS sites. You will drive CAPA, audits, training and process improvements to ensure compliance with global standards and customer requirements.

The role combines on-site leadership at our Chaska, MN headquarters with remote work flexibility, reporting to the VP of Operations, QARA, and Customer Service. A strong background in medical device quality is essential.