We are presently looking for a qualified professional in the position of Quality Manager who would be thrilled to join our Quality Unit team based at our company headquarter at Berlin. The successful applicant must be motivated, goal oriented, structured & passionate to make a positive impact and must be willing to expand his/her knowledge horizons to ensure we deliver best in class quality devices & services to stakeholders. The role will report directly to the VP Q&R, Risk and Safety.
- Assist the QMR in the development and maintenance of MagForce AG QMS.
- Support in QMS digitalization project (non-paper-based document management and training management system) by ensuring to maintain compliance with applicable EN ISO 13485 and MDR 2017/745 requirements.
- Assist RA team and Product Management team in the development of Device Technical Files in compliance with applicable requirements.
- Organization of audit activities for MagForce AG and all sub-organizations of MagForce AG, by liaising with the notified body and regulatory authorities.
- Support the integration and consolidation of QM processes from the contract manufacturer MT MedTech Engineering GmbH to realize the MagForce Q&R process structure.
- Lead and moderate NCR & CAPA committee meetings for resolving deviations / issues reported from internal and external sources.
- Handle and coordinate the changes resulting from the change control process, by ensuring the stability and robustness of the QMS.
- Lead computer system validation activities and support the validation activities at Berlin site. Also, responsible to lead the QA-Validation Engineer.
- Map QMS processes to identify gaps, loops, and areas of improvements.
- Drive continuous improvement efforts for existing QMS processes and support process owners in implementation of lean QMS processes.
- Maintain the PFMEA risk register and support Risk Manager & PRRC Vigilance in EN ISO 14971 compliance activities.
- Drive supply chain improvement activities for processes related to product realization at Magforce AG.
- Perform Basic QM training for the onboarding of new employees.
- Minimum 3-5 years of professional experience by working in a Quality and Regulatory role within a medical device company.
- Ideally working experience with active medical devices is sought.
- Working knowledge of DIN EN ISO 13485:2016, MDR 2017/745, EN 14971:2020, EN 60601 is required. 21CFR Part 820 and MDSAP knowledge is a plus.
- Relevant working experience with Microsoft Office 365 package tools.
- Knowledge of CAPA resolution based on 8-D process and several root cause analysis methods.
- Knowledge of process mapping (ideally Microsoft Visio based) and understanding areas of improvement.
- Knowledge of Kaizen; Lean Six-Sigma is a plus.
- Excellent written and verbal command of German (minimum C1/C2) and English language.
- Good perks and benefits (including company pension scheme)
- Experience based competitive salary
MagForce AG is a world leader in the field of nanotechnology-based tumor therapy, and the first company worldwide to receive European approval for a therapeutic medical device containing nanoparticles. Our medical devices which are collectively termed as NanoTherm® therapy system allows the targeted treatment of glioblastoma tumors through heat by means of superparamagnetic nanoparticles. There are nine medical devices that together comprise the NanoTherm ® therapy system.
For further information, you are most welcome to visit our website www.magforce.de.
Have we piqued your interest to join a future oriented employer involved in dealing with therapies related to the new age cancer treatment?
Then feel free to forward your complete application with a CV and cover letter (also showing your latest entry date and desired compensation) to the following email id: email@example.com.