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Compliance and Quality Leader

2 weeks ago

Aalborg, Ålborg Kommune, Denmark Unique Human Capital AS Full time

Job Summary

We are seeking a Compliance and Quality Leader to join our team at Unique Human Capital A/S.

As a Compliance and Quality Leader, you will be responsible for ensuring the quality management system operates efficiently and supports business objectives.

You will work closely with our departments to develop and implement quality assurance processes aligned with business strategy and priorities.

Main Responsibilities

  • Develop and implement quality assurance processes aligned with business strategy and priorities.
  • Manage CAPA processes, complaints, NCRs, and statistical data analysis.
  • Improve and implement the Quality Management System infrastructure and educate the organisation.
  • Ensure proper preparation and maintenance of technical documentation.
  • Manage the quality management system, including process optimisation and system improvements.
  • Lead audits (internal, external, and supplier audits).
  • Conduct and facilitate risk analyses.

Qualifications

You should have more than 5 years of experience in quality management (ISO13485) and regulatory compliance (MDR, FDA 21 CFR Part 820), preferably within the medical device or a related industry.

You are a person with a strong analytical mindset and a structured approach. You possess a team-minded and hands-on attitude and an action-oriented working style.