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Quality Assurance Specialist

1 month ago

Stockholm, Stockholm, Sweden Permobil Full time

Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at Permobil. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.

Key Responsibilities:

  • Develop, manage, and review Quality Management System (QMS) processes to ensure compliance with medical device regulations (MDR, ISO 13485, FDA).
  • Support the management of CAPA, non-conformance, change management, and audits to ensure quality and compliance.
  • Review QMS efficiency, focusing on key processes and reporting to identify areas for improvement.
  • Conduct QA reviews, investigate non-conformance, and manage CAPA to ensure quality and compliance.
  • Serve as an internal auditor and coordinate external audits to ensure quality and compliance.
  • Analyze quality data and identify training needs to ensure quality and compliance.
  • Address Quality Assurance and Regulatory Compliance issues to ensure quality and compliance.
  • Initiate and/or lead projects to improve quality assurance processes to ensure quality and compliance.
  • Coordinate and support on-site audits conducted by external providers to ensure quality and compliance.

Qualifications and Skills:

  • Master's or bachelor's degree preferably in science or engineering.
  • 5 years of working experience in quality assurance or a related field.
  • Good knowledge of quality systems and quality assurance within regulated industries (preferably life-science).
  • Preferred previous experience from Med Tech or Pharma industry (knowledge of applicable regulatory requirements and ISO).
  • Capability in being a manager, leading operations with or without personnel responsibility.
  • Fluent in oral and written English.
  • Strong computer skills including Microsoft Office.

Why Permobil?

  • You'll make a difference every day by contributing to the development of advanced assistive solutions that improve the lives of individuals with disabilities.
  • You'll be part of a collaborative and innovative team that is passionate about pushing the boundaries of technology to deliver innovations that improve lives.
  • You'll have the opportunity to work in an international environment and make a positive impact on a global scale.

Application Process:

We will conduct selection continuously, so please send us your application today or before the latest deadline.

Permobil is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals.