Open Position

Senior Quality Systems Specialist

  • Burnsville, MN

Basic Function

The Senior Quality Systems Specialist position is responsible for the support and ownership 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.

Apply Now →

Responsibilities

  • Develops and maintains quality system procedures to ensure compliance with regulations and industry standards.
  • Leads and 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.
  • 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.

Qualifications

  • Bachelor’s degree in related technical field.
  • 5-7 years of experience in quality assurance or other quality systems role in 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.
  • Lead auditor certification preferred.
  • Demonstrated and impactful project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality-related issues in a timely and effective manner.
  • Advanced computer skills, including statistical/data analysis and report writing skills.
  • Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
  • Excellent attention to detail. Multitasks, prioritizes, and meets deadlines promptly.
Imricor is an equal opportunity employer and encourages diverse candidates to apply.