Quality Manager (m/f)
Now’s our time to inspire the future of healthcare together.
We at Siemens Healthineers are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind.
While we are investing in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also investing in our 48.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in the healthcare industry.
Join our team now at Siemens Healthineers as Quality Manager (m/f) in Köln.
If you are ambitious and change makes you thrive, then be responsible for the quality management aspects of our software and in-vitro diagnostic products.
NEO New Oncology GmbH – part of Siemens Healthineers– 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.
- As a Quality Manager (m/f) you maintain and upgrade the QMS to manage compliance to international QM standards, regulations and laws (ISO 13485, CLIA)
- You design and manage compliance of our IVD products and plan, support and track necessary verification & validation as well as improvements activities for our medical devices and quality relevant software
- You provide methodologies, processes software and IT infrastructure qualification
- You develop and perform trainings on QM specific topics
- You perform post market surveillance, vigilance reporting activities,
- You are responsible for the definition of Immediate Actions, Corrections, Corrective- and Preventive Actions (CAPA),
- You 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
- You support and lead creation and maintenance of documentation for design control, risk management and change control of our products
This position may suit you best, if you have experience in the IVD / medical device industry with a strong focus on software as a medical device.
- You have a university degree in chemistry, biology, medical device engineering or related disciplines or equivalent combination of education and experience
- You have 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
- You bring sound knowledge of QM requirements for medical devices (ISO, CFR, GMP) and software as a medical device (ISO 62304) and quality relevant software (Gamp5)
- Hands-on software experience is a plus
- You have a deep understanding of improvement process, complaint handling, and practical audit experiences
- You are fluent in English (verbal and written)
- Organization and planning skills as well as presentation, communication, negotiation and interpersonal skills roud off your profile
If you want to join us in transforming the way healthcare is delivered, get in touch with us.
if you wish to find out more about the specific business before applying.
+49 (9131) 7-35335
if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Ms. Ilonka Schönemann.
if you would like to find out more about jobs & careers at Siemens Healthineers.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Requisition ID: 288742
Organization: Siemens Healthineers
Career Level: Early Professional