Quality Assurance (QA) Manager R&D at Medis Medical Imaging Systems
Objectives of the function are:
- Quality management system (QMS) needs to be compliant with applicable European laws and standards.
- Medis products need to be compliant with international regulations (other than CE) for medical devices.
Tasks and Responsibilities
- Raise awareness amongst Medis R&D staff on quality related aspects of product development.
- Assure that Medis products for clinical use are developed in accordance with the QMS.
- Keep knowledge up to date with respect to applicable European laws and standards.
- Maintain the QMS, in order to stay compliant with the applicable European laws and standards.
- Provide training on QMS processes.
- Execute (internal and external) R&D-related audits in order to show compliance of daily work with the QMS processes.
- Explain regulatory background of QMS fundamentals.
- Support in preparing submissions to notified bodies (like SGS) or international regulatory authorities.
- Support Medis’ staff when answering QA or European regulatory questions received from partners and customers.
- Approve R&D product releases from the QA and European regulatory perspective.
- Prescribe changes to the QMS needed for maintaining European regulatory compliance.
- Inform VP R&D and MT with respect to observed violations of the QMS processes.
Education, Experience and Competencies
- Bachelor or Master degree, or level way of working.
- Knowledge of (international) regulations with respect to medical devices, especially for CE certification (MDR, ISO 13485).
- Knowledge of software development fundamentals.
- At least 3 years of experience in QA or regulatory function in the medical sector.
- Committed and pro-active.
- Accurate, reliable, attention for details.
- Strong communication skills.
- Excellent written and spoken English and preferably Dutch.
As an SME Medis medical imaging systems is a highly innovative company, where analytical software is developed for the accurate and quantitative analysis of medical images in the cardiovascular domain. Medis’ products are used in the field of interventional cardiology (using X-ray and IVUS / OCT imaging) and for noninvasive diagnostics (using MRI and MSCT imaging). Our products support medical specialists in the diagnosis and treatment of cardiac patients, and in executing their clinical research. Medis has close collaboration with key-opinion-leaders in the field and our software is distributed worldwide. Over the 25 years of its existence, Medis has obtained a strong brand-name world-wide: we are a global highly-respected player.
As a Quality Assurance Manager R&D you will work from our corporate office in Leiden, which is located next to the Leiden Central Station and also close to our primary research partner, the Leiden University Medical Center (LUMC)
- A stimulating work environment with highly educated professionals, working on innovative products
- A position in a field with significant growth potential and high societal relevance
- A market-conform salary including attractive secondary conditions
We do not accept unsolicited applications from recruitment agencies.