Quality Management System Professional

4 days ago


Stockholm, Stockholm, Sweden TN Sweden Full time
Role Overview

We are looking for a highly skilled Quality Assurance Specialist to join our team at TN Sweden.

The role involves developing and maintaining quality processes that ensure compliance with regulations, including Medical Device Regulation (MDR), Quality System Regulation (QSR), and ISO 13485.

Key Responsibilities:

  • Develop, manage, and review Quality Management System (QMS) processes to ensure compliance and efficiency.
  • Support CAPA, non-conformance, change management, and audit processes to maintain quality assurance.
  • Examine quality data to pinpoint training needs and implement effective solutions.
  • Address Quality Assurance and Regulatory Compliance concerns, driving process improvements.
  • Lead projects aimed at enhancing quality assurance processes, fostering a culture of excellence.
  • Coordinate and support on-site audits conducted by external providers.

Requirements

  • Bachelor's or master's degree in a relevant field, preferably science or engineering.
  • Minimum 5 years of working experience in a regulated industry, preferably life sciences.
  • Strong knowledge of quality systems and quality assurance principles.
  • Prior experience in Med Tech or Pharma industry preferred, with familiarity with applicable regulatory requirements and ISO standards.
  • Proven leadership skills, with ability to lead operations with or without personnel responsibility.
  • Fluent English language proficiency, both written and spoken.


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