Reports to the Director Quality and Regulatory Affairs
Location: Gothenburg, Sweden
ABOUT THE ROLE
Integrum AB is looking for a Quality Assurance Engineer to strengthening our team to enable future international growth. The main responsibilities are to ensure quality compliance within the fields of post-market surveillance, supply chain, non-conformity and CAPA and product release.
The position is part of the Quality and Regulatory team, it is a diverse role supporting the different parts of the organization. If you like variety in your day-to-day work and the opportunity to make an impact, this can be a great place for you!
Integrum is a rapidly expanding medical device company on an exciting and challenging growth journey, that you can contribute to. You will work with unique products that change people’s everyday life. If this is right for you, and you are the right person with the right mindset, there will be good opportunities to develop with the company.
- Develop and maintain systems for collecting, analyzing and providing reports on non-conformity and complaint statistics
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Drive, investigate and analyze complaint cases and work with authorities regarding vigilance/medical device reporting
- Actively participate in and drive development and continuous improvement, maintenance of and adherence to documented processes
- Ensure the awareness of quality, customer and statutory requirements throughout the organization
- Actively participate in internal and external audits
- Authority to initiate corrections, corrective and preventive actions to ensure safe and effective products and compliance with applicable quality regulations and standards
- Ensure quality compliance and the optimization of quality system procedures
- Experience from quality assurance work, preferably from the MedTech industry, minimum 5 years
- Relevant university degree in engineering, medical device technology or scientific field
- Experience of ISO 13485, QSR, MDD/MDR and ISO 14971
- Experience of driving process development and continuous improvements
- Hands-on experience of vigilance/ medical device reporting, Notified Body audits is a merit
- Good understanding of the medical device regulations and related standards
- Excellent oral and written communication skills in both Swedish and English
- Ability to work independently within area of responsibility
- Ability to communicate effectively with both internal and external stakeholders
- Ability to travel, both domestic and international travels will be required
To be successful in this role you are structured, thorough and get things done. We are looking for a problem-solver with good collaboration and prioritization skills. Someone that likes challenges, both on a detailed and a high level. If you also have a positive mindset, are a proactive team player, you may be the one we are looking for!
- Full-time employment, the position is based in Gothenburg
- Competitive salary commensurate with background and qualifications
Since its start in 1998, Integrum AB has been helping individuals with amputations get improved quality of life. Decades of scientific research and development within the field of osseointegration has generated the OPRA TM Implant System for bone-anchored prostheses. This unique approach, utilizing implants of titanium alloy and scientifically well documented concept of osseointegration, offers significant advantages for the patient compared to traditional socket prostheses. Among these advantages are the ability to once again feel the ground beneath your feet, avoid the pain and discomfort of a chiding socket, and to wear the prosthesis for a longer period every day.
Integrum AB is a world leader in this area, and patients are being treated in state-of-the-art clinical facilities spread across the globe. The OPRATM Implant System has been in use since the first treatment in 1990, and today more than 500 patients are using an osseointegrated prosthesis replacing an arm, a leg, or a digit. Integrum is also the only company in the world to have received a PMA (Pre-market Approval) from the FDA, for its products used in the treatment of above-knee amputations.
Questions regarding this position: contact CEO María López, at email@example.com or +46 70 846 10 69
To apply for this position, please send your CV and cover letter to firstname.lastname@example.org, no later than September 3rd, 2021.
Interviews will take place continuously during the process