Quality assurance specialist

Integrum is the world leader in the field of bone-anchored prosthetics with over 25 years of experience on Osseointegration and medical devices.

Our technology, the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, has improved the lives of hundreds of amputees around the world, and we continue striving to provide better solutions. Performing continuous research and development, Integrum aims at providing safe medical devices, supporting a more active life-style and improving quality of life.

Integrum is currently looking for an Quality Assurance Specialist. This position plays an vital role in the quality compliance work.

Position summary

The Quality Assurance Specialist will ensure quality compliance within the fields of post-market surveillance, non-conformity, CAPA and product release.

The Quality Assurance Specialist will cooperate with all functions in the organisation to ensure that quality issues are resolved, and that the quality management system is continuously improved and effective. The role will interact with the company’s all different departments in Sweden and in the US and authorities world wide and has therefore a high demand on communication skills, a strong ability to multitask and professional approach.

Responsibilities

Post market surveillance process

  • Maintain system for customer complaints and non-conformities
  • Provide organization with monthly and annual customer complaint and non-conformity status reports
  • Drive and follow up customer complaint cases
  • Ensure timely manner vigilance/ medical device reporting
  • Drive and follow-up supplier complaints
  • Drive and follow up Corrective and Preventive Actions (CAPA)

Final product release

  • Review of supplier batch documentation
  • Issue final LOT release documentation
  • Approve or reject concessions

Ensure quality compliance

  • Optimization and implementation of quality system procedures
  • Actively participate in preparation of external audits
  • Participate in internal and external audits
  • Employee training where necessary

Qualifications

Required

  • Minimum of three years’ professional experience of a similar role
  • In-depth knowledge of ISO 13485, FDA QSR, MDD and ISO 14971
  • Knowledge about MDR, FSCA and Incident reporting
  • Relevant university degree in engineering, Biomedical engineering or scientific field
  • Excellent verbal and written communication skills in both Swedish and English
  • Good abilility to organize, plan and follow up activities in timely manner
  • Good ability to complete administrative tasks with limited supervision

Desirable experience

  • Experience of NB audits and FDA inspections is a merit
  • Experience of working in a global and rapidly expanding company is seen as an advantage

As a Quality Assurance Specialist, you have the ability to engage and involve the people around you in quality programs and continuous improvements. You enjoy a changing environment and have a good ability to prioritize and get things done. You have a good understanding of the medical device regulations and related standards, as this is part of the daily work. To be successful in this role you need to be well organized, thorough, motivated and interested in the field. You thrive in a small organisation with a broad range of responsibilities. We are looking for a proactive person with a positive mindset. If you are a pragmatic team player, you can be the one we are looking for!

This is a full-time permanent position based in Gothenburg with a 6-month trial period.

Applications

Please submit your cover letter and CV to Niklas Hofverberg at niklas.hofverberg@integrum.se