Quality Systems Specialist II

Job overview

The Quality Systems Specialist II role is onsite in Burnsville, MN. The posting states an expected salary range of $75,000–$110,000. The role supports Imricor Medical Systems’ compliant and effective quality management system. The role exists to maintain quality processes and support regulatory compliance across the product lifecycle. It manages CAPA, nonconformance, audits, document control, change control, training, and quality metrics while collaborating with cross-functional teams.

What you'll do

• Develop and maintain quality system procedures
• participate in internal and external audits
• lead or support CAPA projects
• investigate quality issues and conduct root-cause analysis
• monitor quality metrics
• provide backup support for engineering change orders and document requests
• maintain electronic quality management processes
• train and support cross-functional teams
• communicate quality system updates.

What we're looking for

Skills & competencies

quality systems specialist

quality management system

medical devices

capa

nonconformance management

quality audits

iso 13485

eu mdr

burnsville mn

imricor medical systems

$75k–$110k salary

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision benefits
• health savings accounts
• health care and dependent care flexible spending accounts
• disability benefits
• life insurance
• retirement benefits.

Why this role

Requires a related technical bachelor’s degree, 3–5 years of quality systems or assurance experience in the medical device industry, and knowledge of 21 CFR Part 820, ISO 13485, and EU MDR.

About the employer

Imricor Medical Systems Inc is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.