Quality Systems Specialist II

Exempt position located in Burnsville, MN.

About the Role

The Quality Systems Specialist II supports a compliant and effective quality management system, focusing on Corrective Action and Preventive Action (CAPA), Nonconformance Management, Internal and External Audit, Document and Records Management, Change Control, Training, and Quality Metric Analysis and Review.

Responsibilities

• Develops and maintains quality system procedures to ensure compliance with regulations and industry standards.
• Participates in internal and external quality audits to ensure compliance with regulations and standards.
• Leads or participates in CAPA projects, ensuring compliance, quality, and timeliness of records.
• Investigates and resolves quality issues, including conducting root cause analysis and implementing corrective and preventive actions.
• Leads meetings and communications for CAPA updates, information, and concerns.
• Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions.
• Provides backup support for engineering change orders and other document change requests.
• Develops and maintains electronic quality management system processes.
• Provides cross-functional training and support as needed.
• Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
• Communicates quality system updates and changes to relevant stakeholders.
• Provides guidance and training to the organization on quality system requirements and best practices.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in a related technical field.
• 3-5 years of experience in quality assurance or other quality systems roles in the medical device industry.
• Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies.
• Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Strong verbal and written communication skills.
• Excellent attention to detail.
• Ability to multitask, prioritize, and meet deadlines promptly.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• 85% of time requires viewing and working at a computer screen.

Pay

The expected salary range for this Minnesota-based position is $75,000–$110,000, with specific compensation varying based on factors such as knowledge, skills, and experience.

Benefits

• Medical, Dental, and Vision coverage
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Retirement Benefits