Quality Assurance Manager

2 months ago


Malmo, Skåne, Sweden Norrsken Foundation Full time
About the Role

We are seeking a highly skilled Quality Assurance Manager to join our team at Norrsken Foundation. As a key member of our organization, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities
  • Develop and implement quality management systems to ensure compliance with regulatory requirements
  • Lead cross-functional teams in risk management activities to identify and mitigate potential risks
  • Collaborate with stakeholders to ensure effective communication and coordination
  • Participate in software development processes to ensure design controls are followed
  • Ensure product documentation is generated and kept up to date
Requirements
  • At least 5 years of experience in a Quality Assurance role, preferably in a management position
  • Experience working with Medical Device Software (MDSW) or Software as a Medical Device (SaMD)
  • Understanding of international regulations and standards, such as FDA QSR, MDR, ISO 13485, IEC 62304, and ISO 14971
  • Excellent analytical and troubleshooting skills, with a true quality mindset
  • Strong interpersonal, writing, and communication skills
What We Offer
  • Employee stock ownership plan
  • Occupational pension
  • 36-hour work week, with Fridays off
  • 30 days of vacation per year, increasing to 35 days after two years
  • Yearly wellness allowance of 3000 SEK
  • Coverage of mobile phone bill up to 1000 SEK per month
About Us

Norrsken Foundation is a growing organization dedicated to creating a healthier and more sustainable world. We are committed to our cause, basing our work on scientific evidence and assessing both quantitative and qualitative data through user testing and scientific papers.

We value a safe, inclusive, welcoming, and collaborative environment, and we strive to take care of our mental and physical well-being. We are committed to continuous improvement and are not afraid to fail, as we strive for positive change through learning, adapting, and iterating.



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