Senior Quality Systems Leader - Medical Devices (QMS)

IMRIS; Chaska (MN); Hybrid; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) savings plus matching

Flexible Spending Account

Life Insurance

Disability Insurance

Vision Insurance

Generous PTO

Incentive bonus

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Management

CAPA

Audits

Regulatory compliance

Documentation

Process improvement

Ausbildung

Bachelor’s degree in engineering or related field

Tools

Arena eQMS

PLM system

MS Office

Jobbeschreibung

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.