Quality Engineer - Bonesupport in Lund

BONESUPPORT™ (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The Company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver and a Premarket Premarket approval filing with the FDA (USA) for CERAMENT G was received in May 2022. The company is based in Lund, Sweden, and the net sales amounted to SEK 181 million in 2020. Please visit www.bonesupport.com (http://www.bonesupport.com) for more information.

The role
As Quality Engineer at BONESUPPORT you are responsible for implementation of new products, components and processes, or changes of the same in the Operations organization. This includes for example to ensure adequate manufacturing documents and specifications in the design documentation (Design History File). You will represent Operations in project teams and change order teams to ensure smooth transfer/design transfer from R&D to Operations, including relevant documents in the DMR (Device Master Record). You will also be responsible for putting together the DHR (Device History Record) and handle the day-to-day batch production release flow. All work is documented in the Quality Management System (MasterControl) and in the ERP system (Navision).

Besides the above mentioned documentation tasks, you will also work with our suppliers, to help implement and organize changes of material, processes or components. Other tasks like root cause investigations, corrective and preventive actions (CAPA) and to solve deviations and non-conformances are also within the role. Additionally, other tasks are within release procedure and quality control. The position involves daily cooperation internally, for example with your colleagues in Operations, QA/RA and R&D, and externally, with our suppliers. You will report to the Director of Operations and will be based in our HQ in Lund.



The profile
We believe you have a university degree within Engineering or as Pharmacist. You have at least 3 years experience from a similar position, preferably from the medical device industry. Most likely, you are today working with quality in close cooperation with R&D and production. It is a strong merit if you are familiar with Design Control and have experience from transferring products from R&D to production. You understand what it means and enjoy working in an international environment and you are process-oriented and you love documentation. High level of English is required, both written and spoken.

At BONESUPPORT we value personal skills as much as professional qualifications, and in this role we are looking for a quality oriented and structured person with good communication skills. Yor are thorough and organized, even meticulous, but still dynamic and pragmatic. It is not the square type of quality person we are looking for - instead you understand other peoples’ situation and you make life easier for people around you. You also like to drive, coordinate and to take ownership of activities. It is important to be able to develop strong working relationships with key stakeholders and to have a positive and ''can do'' attitude!

Why BONESUPPORT?
At BONESUPPORT you will be working together with skilled, dedicated people who enjoy working in a fast growing and innovative organization. You will work in a broad role where you build relationships with colleagues from all departments. We offer a dynamic and stimulating workplace and strive for generating great teamwork, innovation, passion, and performance - which is reflected in impressive employee engagement figures. We believe in our journey and take pride in what we do. In May 2022 Bonesupport got the FDA approval of Cerament G for the US market - which is an enormous commercial success. You can literally feel the positive energy in the company.

Information and application
For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, www.toblor.se, by uploading your CV and personal letter.

We are looking forward to seeing your application!