Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
As a Siemens Healthineers company, NEO New Oncology GmbH is a dynamically growing diagnostics company offering products for molecular tumor profiling 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. Within NEO, we make a difference in the lives of people in need of cancer diagnostics to support therapy optimization and improved outcomes.
This is a role well suited to an ambitious professional, looking for the next step in your career.
Your tasks and responsibilities:
- You will lead and manage the Quality and Regulation team and interact with the Management Team
- You will be responsible for the overall Quality, Clinical and Regulatory activities at the company
- Your duties will include supporting the business with QM & Regulatory strategies and coordinate clinical trial activities
- You will create and implement new QMS processes and/or give direction to others for process creation or improvements
- You will coordinate applicable parts of Site QMS with overall Siemens Healthineers, Molecular Services business QMS requirements
- You will assure compliance with all applicable regulations, laws and standards
- Maintaining effect working relationship with applicable accrediting and regulatory agencies, administrative officials and the medical community is also one of your responsibilities
To find out more about the specific business, have a look at www.newoncology.com
Your qualifications and experience:
- You have successfully completed a degree in a Natural Science
- You have a sound knowledge in IVD or MD Quality/Regulatory and longterm experience in the mentioned field
- You are intimately familiar with the IVDD, IVDR, German Medical Device Law, GDPR, ISO 13485, 42 CFR 493 (CLIA) and ISO standards applicable to IVDs
Your attributes and skills:
- You have proven leadership skills, either in special projects, or managing a team
- As the leader for Quality, you have strong decision-making skills in addition to excellent interpersonal and written skills
- You have good PC skills (MS Office software (Word, PowerPoint, Excel and Outlook)
- You will be working with our latest technology and therefore you are willing to learn the latest in Next Generation Sequencing, basic genetics, oncology and clinical applications of this technology
- Since you are interacting with international colleagues, excellent English & German skills (spoken and written) are necessary and knowledge of other languages is of advantage
- You enjoy teaching people regarding quality topics to help bring up their skill level
- Your experience in another field like R&D, Marketing or Customer Service would be helpful for ease of QM system implementation into other groups
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at www.healthcare.siemens.de/careers
As an equal opportunity employer, we welcome applications from individuals with disabilities. Applications from individuals with disabilities
Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Arne Wassermann
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To all recruitment agencies:
Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our job alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Job ID: 119772
Organization: Siemens Healthineers
Company: NEO New Oncology GmbH
Experience Level: Experienced Professional
Job Type: Full-time