Quality Systems Specialist II

Imricor Medical Systems Inc • Burnsville, MN

79d • $75,000 - $110,000 • Onsite

About The Position

The Quality Systems Specialist II position is responsible for the support of a compliant and effective quality management system. Primary quality system functions include 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.

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.
• Multitasks prioritize and meet deadlines promptly.

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.
• Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records.
• Investigate and resolve 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level