Looking for a job in a fast-growing, flexible and dynamic company, but without missing out on the advantages of working in a large, global corporation?
NEO New Oncology GmbH – a Siemens Healthineers Company – is a dynamically growing diagnostics company offering products for molecular diagnostics to identify optimal treatment options for cancer patients. Our technology platform “NEO” is based on next generation sequencing and proprietary computer algorithms. NEO reliably identifies therapy-relevant genetic alterations from standard clinical material such as FFPE specimens and liquid biopsies with short turnaround times and highest accuracy.
NEO New Oncology employs specialists in the fields of cancer genomics, translational medicine, bioinformatics and diagnostic quality assurance.
To expand our current capabilities, we are seeking a highly motivated
Quality Manager (m/f)
We are looking as soon as possible for a quality manager with experience in the IVD / medical device industry with a strong focus on software as a medical device. You will work cross functionally being responsible for the quality management aspects of our software and in-vitro diagnostic products. Excellent English verbal and written skills are mandatory and German is a plus.
- Maintain and upgrade the QMS to manage compliance to international QM standards, regulations and laws (ISO 13485, 17025, CLIA),
- You will design and manage compliance of our IVD products and will plan, support and track necessary verification & validation as well as improvements activities for our medical devices and quality relevant software,
- Provide methodologies, and processes software and IT infrastructure qualification;
- Development and perform trainings on QM specific topics,
- Perform Post market surveillance, vigilance reporting activities,
- Definition of Immediate Actions, Corrections, Corrective- and Preventive Actions (CAPA),
- Support in-house functions for the effective implementation of regulatory requirements during product development and life cycle management (IVD and software) with respect to risk management for product quality, patient safety and data integrity as well as usability,
- Support and lead creation and maintenance of documentation for design control, risk management and change control of our products,
- Reports to the Head of Quality Management.
- Degree in chemistry, biology, medical device engineering or related disciplines or equivalent combination of education and experience and a strong affinity to IT,
- at least two years’ experience as quality manager in a medical device / IVD company with focus on development and life cycle management for software as a medical device,
- Sound knowledge of QM requirements for medical devices (ISO, CFR, GMP) and software as a medical device (ISO 62304) and quality relevant software (Gamp5),
- Understanding of Improvement process, Complaint handling, and practical audit experiences,
- Organization and planning skills,
- Presentation, communication, negotiation and interpersonal skills,
- Project management skills / training,
- hands-on software experience is a plus.
What we offer
- Be part of a young, dynamic, fast-growing company,
- Working in a dedicated team of quality managers, regulatory affairs managers and IT specialists,
- Possibility to develop further.
Type of Position: Permanent full-time (40 h/week)
Location: Cologne, Germany
Please send your CV, cover letter, academic transcript and testimonials to Sebastian Bartel, Head of Quality Management at email@example.com. Please indicate the job title in the header of your e-mail.